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    Clinical Trial Results:
    BEL114424: A Phase 2 Pilot, Multicentered, Randomised, Double Blind, Placebo-Controlled Study to Evaluate the Potential for Efficacy and the Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in the Prevention of Allograft Rejection in Adult Subjects After Renal Transplantation.

    Summary
    EudraCT number
    		 2011-006215-56
    Trial protocol
    		 GB  
    Global end of trial date
    08 Feb 2016

    Results information
    Results version number
    		 v1
    This version publication date
    21 Oct 2016
    First version publication date
    21 Oct 2016
    Other versions
    		 v2

    Trial information

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    Trial identification
    Sponsor protocol code
    114424
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jun 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Efficacy: To estimate the change in naïve B cells following belimumab 10 mg/kg (or placebo) in addition to standard of care immunosuppressants in renal transplant patients from the time of transplantation up to 24 weeks. Safety: To assess the safety and tolerability of belimumab 10 mg/kg (or placebo) in renal transplant patients in addition to standard of care immunosuppressants.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Sep 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 25
    Worldwide total number of subjects
    25
    EEA total number of subjects
    25
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    22
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 25 renal transplant recipients were enrolled. Participants were randomized to 1 of the 2 treatments groups in a 1:1 ratio and received standard of care in addition to investigational products (IPs). Participants received IP infusion on Day 0, Day 14, Day 28 and every 4 weeks thereafter for a total of 7 infusions.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2)

    Arm title
    		 Belimumab 10mg/kg
    Arm description
    		 Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Belimumab 10mg/kg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2)

    Number of subjects in period 1
    		Placebo Belimumab 10mg/kg
    Started
    13
    12
    Completed
    11
    9
    Not completed
    2
    3
         Adverse event, serious fatal
    1
    -
         Consent withdrawn by subject
    1
    1
         Adverse event, non-fatal
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Reporting group title
    Belimumab 10mg/kg
    Reporting group description
    		 Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Reporting group values
    		 Placebo Belimumab 10mg/kg Total
    Number of subjects
    		 13 12
    Age categorical
    Units: Subjects
    Age continuous
    Age continuous description
    Units: years
        arithmetic mean (standard deviation)
    		 51 ( 14.02 ) 54.3 ( 11.02 ) -
    Gender categorical
    Gender categorical description
    Units: Subjects
        Female
    		 4 7 11
        Male
    		 9 5 14
    Race/Ethnicity, Customized
    Units: Subjects
        White/Caucasian
    		 12 11 23
        Asian
    		 1 1 2

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Reporting group title
    Belimumab 10mg/kg
    Reporting group description
    		 Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Primary: Change from Baseline in naïve B cells from Baseline to Week 24

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    End point title
    		 Change from Baseline in naïve B cells from Baseline to Week 24
    End point description
    Naive B cell is cell that is not exposed to antigen. Naïve B cell count is CD20+CD27 concentration of cells (conc-cell)/cubic millimeter (cumm). Change from Baseline in naïve B cells was calculated as the value at Week 24 minus the value at Baseline. MITT Population consisted of all participants randomized to treatment, who have had taken at least one dose of study. Participants analyzed included those who had data at Week 24 for naïve B cells count (MITT Population). Baseline value used in the analysis was of Day 0 (Day of transplant). Adjusted mean differences (treatment-placebo) and 95% confidence intervals for differences were obtained from mixed-models repeated-measures (MMRM) model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments.
    End point type
    Primary
    End point timeframe
    Baseline and Week 24
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    9 [1]
    7
    Units: Conc-cells/cumm
        least squares mean (standard error)
    4 ( 25.55 )
    -30.4 ( 27.5 )
    Notes
    [1] - Modified Intent to treat (MITT) Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    16
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -34.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -109.5
         upper limit
    		 40.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    37.24

    Primary: Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse Events of Special Interest (AESI)

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    End point title
    		 Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse Events of Special Interest (AESI) [2]
    End point description
    Number of participants with AEs, SAEs and AESI are summarized. The On-treatment (OT) phase started on the day and time of receiving the start of the first infusion and ended on the last dose date plus 28 days. The Post-treatment (PT) phase started 29 days after day of last dose up to 1 year. An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in, death, is life threatening, Requires hospitalization or prolongation of existing hospitalization, Results in disability/incapacity, Is a congenital anomaly/birth defect or event that but may jeopardize the subject or may require medical or surgical intervention to prevent one of the other outcomes listed. AESI included malignant neoplasms, infusion/anaphylaxis/hypersensitivity reactions, all infections, depression/suicide/self-injury, deaths.
    End point type
    Primary
    End point timeframe
    Up to 1 year
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [3]
    12
    Units: Participants
        OT AEs
    10
    11
        PT AEs
    9
    10
        OT SAEs
    7
    5
        PT SAEs
    2
    2
        Malignant neoplasms
    0
    0
        Post-Infusion Systemic Reactions
    0
    1
        All Infections
    6
    7
        Depression/suicide/self-injury
    0
    0
        Deaths
    1
    0
    Notes
    [3] - mITT Population
    No statistical analyses for this end point

    Primary: Number of incidence of all infections and serious infections

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    End point title
    		 Number of incidence of all infections and serious infections [4]
    End point description
    All infections included: 1. Opportunistic infections per-clinical assessment, 2. Herpes Zoster, a. Recurrent, b. Disseminated, 3. Sepsis. Opportunistic infections were identified using list of preferred terms as per Medical Dictionary for Regulatory Activities (MedDRA) version 18.1. Any events falling under these preferred terms were adjudicated to determine if criteria was met for an opportunistic infection.
    End point type
    Primary
    End point timeframe
    Up to 1 year
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [5]
    12
    Units: Incidence of Infections
        All Infections
    8
    7
        Serious Infections
    2
    1
        All Opportunistic Infections
    7
    5
        Serious Opportunistic Infections
    1
    0
        All Herpes Zoster
    0
    1
        Serious Herpes Zoster
    0
    0
        Sepsis
    3
    2
        Serious Sepsis
    2
    1
    Notes
    [5] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Week 24 and Week 52 [6]
    End point description
    Change from Baseline in SBP and DBP were assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [7]
    12
    Units: millimeter of mercury (mmHg)
    arithmetic mean (standard deviation)
        DBP Week 24; n=9, 7
    -4.444 ( 14.3275 )
    7.286 ( 13.8289 )
        DBP Week 52; n=11, 10
    -6.545 ( 13.9668 )
    4.2 ( 8.5479 )
        SBP Week 24; n=9, 7
    2 ( 26.096 )
    10 ( 35.9444 )
        SBP Week 52; n=11, 10
    -2.909 ( 27.2046 )
    3.3 ( 27.9008 )
    Notes
    [7] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in heart rate from Baseline at Week 24 and Week 52

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    End point title
    		 Change from Baseline in heart rate from Baseline at Week 24 and Week 52 [8]
    End point description
    Change from Baseline in heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [9]
    12
    Units: Beats per minute (BPM)
    arithmetic mean (standard deviation)
        Week 24; n=8, 6
    5.125 ( 16.8983 )
    1.5 ( 13.6345 )
        Week 52; n=11, 9
    2 ( 11.5065 )
    -2.444 ( 15.42 )
    Notes
    [9] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in body temperature from Baseline at Week 24 and Week 52

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    End point title
    		 Change from Baseline in body temperature from Baseline at Week 24 and Week 52 [10]
    End point description
    Change from Baseline in body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value at Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [11]
    12
    Units: Degree Centigrade
    arithmetic mean (standard deviation)
        Week 24; n=8, 6
    0.025 ( 0.7025 )
    -0.233 ( 0.5007 )
        Week 52; n=11, 10
    -0.045 ( 0.4803 )
    0.03 ( 0.5417 )
    Notes
    [11] - mITT Population
    No statistical analyses for this end point

    Primary: Number of participants outside the normal range (NR) for SBP and DBP at Week 24 and Week 52

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    End point title
    		 Number of participants outside the normal range (NR) for SBP and DBP at Week 24 and Week 52 [12]
    End point description
    Number of participants outside the normal range (NR) for SBP and DBP was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Week 24 and Week 52
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [13]
    12
    Units: Participants
        DBP, > NR, Week 24; n=9, 7
    1
    1
        DBP, < NR, Week 24; n=9, 7
    1
    2
        DBP, > NR, Week 52; n=11, 10
    3
    0
        DBP, < NR, Week 52; n=11, 10
    2
    1
        SBP, > NR, Week 24; n=9, 7
    5
    3
        SBP, < NR, Week 24; n=9, 7
    0
    0
        SBP, > NR, Week 52; n=11, 10
    5
    4
        SBP, < NR, Week 52; n=11, 10
    0
    1
    Notes
    [13] - mITT Population
    No statistical analyses for this end point

    Primary: Number of participants outside the normal range (NR) for heart rate at Week 24 and Week 52

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    End point title
    		 Number of participants outside the normal range (NR) for heart rate at Week 24 and Week 52 [14]
    End point description
    Number of participants outside the normal range (NR) for heart rate was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Week 24 and Week 52
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [15]
    12
    Units: Participants
        > NR Week 24; n=8, 6
    1
    0
        < NR Week 24; n=8, 6
    2
    0
        > NR Week 52; n=11, 9
    0
    0
        < NR Week 52; n=11, 9
    1
    1
    Notes
    [15] - mITT Population
    No statistical analyses for this end point

    Primary: Number of participants outside the normal range (NR) for body temperature at Week 24 and Week 52

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    End point title
    		 Number of participants outside the normal range (NR) for body temperature at Week 24 and Week 52 [16]
    End point description
    Number of participants outside the normal range (NR) for body temperature was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Number of participants outside the normal range are summarized by less than (<) normal range and greater than (>) normal range categories at Week 24 and Week 52. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Week 24 and Week 52
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [17]
    12
    Units: Participants
        > NR Week 24; n=8, 6
    0
    0
        < NR Week 24; n=8, 6
    3
    4
        > NR Week 52; n=11, 10
    0
    0
        < NR Week 52; n=11, 10
    5
    2
    Notes
    [17] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the indicated hematology parameters at Week 24 and Week 52

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    End point title
    		 Change from Baseline in the indicated hematology parameters at Week 24 and Week 52 [18]
    End point description
    Hematology parameters included: basophils (B), eosinophils (E), lymphocytes (L), monocytes (M), total neutrophils (N), platelet count (PC) and white blood cells (WBC). Change from Baseline in haematology parameter was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [19]
    12
    Units: Gills/Liter (GI/L)
    arithmetic mean (standard deviation)
        B Week 24; n=9, 6
    -0.001 ( 0.0215 )
    -0.015 ( 0.0207 )
        B Week 52; n=10, 10
    0.033 ( 0.1024 )
    -0.005 ( 0.0357 )
        E Week 24; n=9, 6
    -0.531 ( 1.025 )
    -0.14 ( 0.1274 )
        E Week 52; n=10, 10
    -0.392 ( 0.8048 )
    -0.127 ( 0.1489 )
        L Week 24; n=9, 6
    -0.218 ( 0.6457 )
    -0.347 ( 0.3467 )
        L Week 52; n=10, 10
    0.085 ( 0.5841 )
    -0.245 ( 0.3357 )
        M Week 24; n=9, 6
    -0.097 ( 0.2231 )
    -0.365 ( 0.3509 )
        M Week 52; n=10, 10
    0.001 ( 0.1799 )
    -0.111 ( 0.3892 )
        TN Week 24; n=9, 6
    0.946 ( 2.6602 )
    -0.083 ( 2.4752 )
        TN Week 52; n=10, 10
    1.657 ( 3.5533 )
    -0.606 ( 3.3406 )
        PC Week 24; n=9, 6
    15.9 ( 59.64 )
    7.3 ( 40.35 )
        PC Week 52; n=11, 10
    18.1 ( 55.81 )
    -10 ( 54.14 )
        WBC Week 24; n=9, 6
    0.1 ( 3.483 )
    -0.95 ( 2.868 )
        WBC Week 52; n=11, 10
    1.47 ( 3.572 )
    -1.11 ( 3.557 )
    Notes
    [19] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the haematology parameter- hemoglobin at Week 24 and Week 52

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    End point title
    		 Change from Baseline in the haematology parameter- hemoglobin at Week 24 and Week 52 [20]
    End point description
    Change from Baseline in hemoglobin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [21]
    12
    Units: Grams per Liter (G/L)
    arithmetic mean (standard deviation)
        Week 24; n=9, 6
    5.4 ( 24.84 )
    13.2 ( 28.9 )
        Week 52; n=11, 10
    12.6 ( 22.69 )
    6.3 ( 23.48 )
    Notes
    [21] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in the hematology parameter- hematocrit at Week 24 and Week 52

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    End point title
    		 Change from Baseline in the hematology parameter- hematocrit at Week 24 and Week 52 [22]
    End point description
    Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [23]
    12
    Units: Percentage of blood
    arithmetic mean (standard deviation)
        Week 24; n=9, 6
    0.0216 ( 0.06625 )
    0.0477 ( 0.0954 )
        Week 52; n=11, 10
    0.0434 ( 0.06813 )
    0.0238 ( 0.07045 )
    Notes
    [23] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in haematology parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in haematology parameter- Mean Corposcular Hemoglobin (MCH) at Week 24 and Week 52 [24]
    End point description
    Change from Baseline in MCH was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [25]
    12
    Units: Picogram (pg)
    arithmetic mean (standard deviation)
        Week 24; n=8, 6
    -0.79 ( 2.173 )
    -1.37 ( 2.683 )
        Week 52; n=10, 10
    -1.59 ( 1.516 )
    -1.93 ( 2.743 )
    Notes
    [25] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in haematology parameter- mean corposcular volume (MCV) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in haematology parameter- mean corposcular volume (MCV) at Week 24 and Week 52 [26]
    End point description
    Change from Baseline in MCV was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [27]
    12
    Units: Femtoliter (FL)
    arithmetic mean (standard deviation)
        Week 24; n=9, 6
    -1.73 ( 6.43 )
    -2.55 ( 8.198 )
        Week 52; n=11, 10
    -3.58 ( 4.34 )
    -4.61 ( 7.041 )
    Notes
    [27] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in haematology parameter- red blood cell (RBC) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in haematology parameter- red blood cell (RBC) at Week 24 and Week 52 [28]
    End point description
    Change from Baseline in RBC was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [29]
    12
    Units: Tera (TI)/L
    arithmetic mean (standard deviation)
        Week 24; n=9, 6
    0.298 ( 0.6716 )
    0.645 ( 0.8097 )
        Week 52; n=11, 10
    0.635 ( 0.7064 )
    0.468 ( 0.5884 )
    Notes
    [29] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in clinical chemistry parameter- albumin at Week 24 and Week 52

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    End point title
    		 Change from Baseline in clinical chemistry parameter- albumin at Week 24 and Week 52 [30]
    End point description
    Change from Baseline in albumin was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [31]
    12
    Units: G/L
    arithmetic mean (standard deviation)
        Week 24; n=9, 7
    4.1 ( 2.62 )
    2.9 ( 4.91 )
        Week 52; n=10, 10
    2.9 ( 3 )
    1.8 ( 4.98 )
    Notes
    [31] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in clinical chemistry parameter- ALP, ALT, AST at Week 24 and Week 52

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    End point title
    		 Change from Baseline in clinical chemistry parameter- ALP, ALT, AST at Week 24 and Week 52 [32]
    End point description
    Clinical chemistry parameter included alkaline phosphatase (ALP), alanine amino Transferase (ALT) and aspartate amino transferase (AST). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [33]
    12
    Units: International Unit (IU)/L
    arithmetic mean (standard deviation)
        ALP Week 24; n=9, 7
    -16 ( 26.14 )
    -5 ( 60.03 )
        ALP Week 52; n=10, 10
    -17.5 ( 35.25 )
    19.9 ( 80.63 )
        ALT Week 24; n=9, 7
    1 ( 15.86 )
    5.1 ( 7.56 )
        ALT Week 52; n=10, 10
    -2.5 ( 11.16 )
    2.1 ( 5.8 )
        AST Week 24; n=6, 3
    3.2 ( 7.91 )
    7.3 ( 4.04 )
        AST Week 52; n=7, 4
    3.3 ( 5.68 )
    9.3 ( 3.86 )
    Notes
    [33] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in clinical chemistry parameter- direct bilirubin, total bilirubin and creatinine at Week 24 and Week 52

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    End point title
    		 Change from Baseline in clinical chemistry parameter- direct bilirubin, total bilirubin and creatinine at Week 24 and Week 52 [34]
    End point description
    Clinical chemistry parameters included direct bilirubin (DB), total bilirubin (TB) and creatinine (C). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [35]
    12
    Units: Micromole per Liter (umol/L)
    arithmetic mean (standard deviation)
        DB Week 24; n=8, 3
    0.6 ( 1.51 )
    -0.7 ( 3.06 )
        DB Week 52; n=9, 5
    0.9 ( 1.54 )
    0.2 ( 1.3 )
        TB Week 24; n=9, 7
    3 ( 6.5 )
    2.7 ( 5.22 )
        TB Week 52; n=10, 10
    2.9 ( 5.26 )
    2.9 ( 3.38 )
        C Week 24; n=9, 7
    -471.1 ( 317.54 )
    -571.3 ( 183.53 )
        C Week 52; n=10, 10
    -468.4 ( 310.54 )
    -609.8 ( 271.89 )
    Notes
    [35] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in clinical chemistry parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52

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    End point title
    		 Change from Baseline in clinical chemistry parameter- Ca, CO2/Bicar, Gl, K, Na, PhI, U/BUN at Week 24 and Week 52 [36]
    End point description
    Clinical chemistry parameters included calcium (Ca), carbon dioxide content/bicarbonate (CO2/Bicar), glucose (Gl), potassium (K), sodium (Na), phosphorus inorganic (PhI), urea/blood urine nitrogen (U/BUN). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [37]
    12
    Units: Millimole (MMOL)/L
    arithmetic mean (standard deviation)
        Ca Week 24; n=9, 7
    0.116 ( 0.1344 )
    0.167 ( 0.1942 )
        Ca Week 52; n=10, 9
    0.116 ( 0.1013 )
    0.128 ( 0.1386 )
        CO2/Bicar Week 24; n=7, 6
    -3.73 ( 5.951 )
    1.7 ( 3.449 )
        CO2/Bicar Week 52; n=8, 9
    -2.68 ( 5.142 )
    0.77 ( 3.588 )
        Gl Week 24; n=5, 5
    0.2 ( 3.093 )
    -0.04 ( 2.003 )
        Gl Week 52; n=5, 8
    -0.32 ( 2.483 )
    1.79 ( 4.107 )
        K Week 24; n=9, 7
    0.06 ( 0.723 )
    -0.63 ( 0.923 )
        K Week 52; n=10, 10
    -0.02 ( 0.535 )
    -0.44 ( 0.877 )
        Na Week 24; n=9, 7
    -0.6 ( 4.03 )
    5.9 ( 5.01 )
        Na Week 52; n=10, 10
    -0.7 ( 3.71 )
    2.2 ( 4.71 )
        PhI Week 24; n=8, 7
    -0.225 ( 0.3843 )
    -0.913 ( 0.5862 )
        PhI Week 52; n=9, 9
    -0.227 ( 0.4234 )
    -0.726 ( 0.5453 )
        U/BUN Week 24; n=9, 6
    -5.91 ( 12.164 )
    -9.47 ( 9.128 )
        U/BUN Week 52; n=10, 9
    -8.13 ( 14.967 )
    -9.01 ( 7.323 )
    Notes
    [37] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in clinical chemistry parameter- glomerular filtration rate (GFR) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in clinical chemistry parameter- glomerular filtration rate (GFR) at Week 24 and Week 52 [38]
    End point description
    Change from Baseline in GFR was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [39]
    12
    Units: milliliter (mL)/Minute (min)
    arithmetic mean (standard deviation)
        Week 24; n=9, 7
    42.8 ( 23.604 )
    44.36 ( 10.731 )
        Week 52; n=10, 10
    42.33 ( 29.14 )
    53.75 ( 15.176 )
    Notes
    [39] - mITT Population
    No statistical analyses for this end point

    Primary: Change from Baseline in immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) at Week 24 and Week 52

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    End point title
    		 Change from Baseline in immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) at Week 24 and Week 52 [40]
    End point description
    Change from Baseline in immunoglobulins IgA, IgG and IgM was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Change from Baseline was calculated as the value on Week 24 and Week 52 minus the value at Baseline. Baseline value used in the analysis was of Day 0 (Day of transplant). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Primary
    End point timeframe
    Baseline, Week 24 and Week 52
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [41]
    12
    Units: G/L
    arithmetic mean (standard deviation)
        IgA Week 24; n=2, 3
    -0.5 ( 0.2828 )
    -0.433 ( 0.6429 )
        IgA Week 52; n=2, 3
    -0.3 ( 0 )
    -0.5 ( 0.5292 )
        IgG Week 24; n=6, 6
    -1.02 ( 1.184 )
    -2.4 ( 1.731 )
        IgG Week 52; n=10, 9
    0.78 ( 3.595 )
    -2.13 ( 1.702 )
        IgM Week 24; n=2, 3
    -0.1 ( 0 )
    -0.133 ( 0.3512 )
        IgM Week 52; n=2, 3
    0 ( 0 )
    -0.333 ( 0.4933 )
    Notes
    [41] - mITT Population
    No statistical analyses for this end point

    Secondary: Median Percent change from Baseline in memory B cell count at Week 24 and Week 52

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    End point title
    		 Median Percent change from Baseline in memory B cell count at Week 24 and Week 52
    End point description
    Memory B cells are B cell sub-type that are formed within germinal centres following primary infection and are important in generating an accelerated and more robust antibody-mediated immune response in the case of re-infection. Memory B cell count included CD20+CD27+ conc-cells/cumm. Baseline value used in the analysis was of Day 0 (Day of transplant). Endpoint was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Percent change from Baseline in Memory B cell count was calculated as the value at Week 24 and Week 52 minus the value at Baseline multiplied by 100. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Median Difference and 95% confidence interval of difference obtained using the Hodges-Lehmann method.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [42]
    12
    Units: Conc-cells/cumm
    median (full range (min-max))
        Week 24; n=9, 7
    -12.5 (-88 to 320)
    177.8 (40 to 800)
        Week 52; n=10, 7
    2.4 (-67 to 340)
    -33.3 (-80 to 44)
    Notes
    [42] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    204.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 90
         upper limit
    		 550
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Median difference (final values)
    Point estimate
    -33.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -169.84
         upper limit
    		 25

    Secondary: Activated memory B cells count at Week 24 and Week 52

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    End point title
    		 Activated memory B cells count at Week 24 and Week 52
    End point description
    Activated memory B cell-CD95% count is CD19+CD27+CD95 conc-cells/mL. Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [43]
    12
    Units: Conc-cells/mL
    least squares mean (standard error)
        Week 24; n=9, 7
    37157.2 ( 16664.42 )
    38389.6 ( 18682.83 )
        Week 52; n=10, 8
    24220.8 ( 15744.17 )
    11092.5 ( 17711.36 )
    Notes
    [43] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    1232.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -50457
         upper limit
    		 52921.8
    Variability estimate
    Standard error of the mean
    Dispersion value
    25735.56
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13128.35
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -61868.9
         upper limit
    		 35612.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    24165.18

    Secondary: Activated memory B cells percentage at Week 24 and Week 52

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    End point title
    		 Activated memory B cells percentage at Week 24 and Week 52
    End point description
    Activated memory B cell-CD95% percentage is CD19+CD27+CD95+ (%CD19/CD27). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [44]
    12
    Units: Percentage of activated memory B cells
    least squares mean (standard error)
        Week 24; n=9, 7
    32.8 ( 5.94 )
    19 ( 6.06 )
        Week 52; n=11, 10
    32 ( 5.07 )
    38.8 ( 5.48 )
    Notes
    [44] - mITT Population
    Statistical analysis title
    		 Statistical analysis 2
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    6.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.6
         upper limit
    		 22.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    7.68
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -13.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.3
         upper limit
    		 3.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.78

    Secondary: Transitional B cells count at Week 24 and Week 52

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    End point title
    		 Transitional B cells count at Week 24 and Week 52
    End point description
    Transitional B cell count (Newell) is CD19+CD24b+CD38b+IgD+ (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [45]
    12
    Units: Conc-cells/mL
    least squares mean (standard error)
        Week 24; n=9, 7
    5470 ( 2910.9 )
    2679 ( 3518.4 )
        Week 52; n=10, 8
    7110 ( 2836.7 )
    6652 ( 3291.5 )
    Notes
    [45] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2791
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -12105
         upper limit
    		 6524
    Variability estimate
    Standard error of the mean
    Dispersion value
    4651.1
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -458
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -9487
         upper limit
    		 8572
    Variability estimate
    Standard error of the mean
    Dispersion value
    4501.8

    Secondary: Transitional B cells percentage at Week 24 and Week 52

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    End point title
    		 Transitional B cells percentage at Week 24 and Week 52
    End point description
    Transitional B cell percentage (Newell) is CD19+CD24b+CD38b+IgD+ (%CD19+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [46]
    12
    Units: Percentage of transitional B cells
    least squares mean (standard error)
        Week 24; n=9, 7
    2.43 ( 0.776 )
    1.14 ( 0.869 )
        Week 52; n=11, 10
    2.61 ( 0.713 )
    3.41 ( 0.731 )
    Notes
    [46] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.59
         upper limit
    		 1.01
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.156
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.24
         upper limit
    		 2.82
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.017

    Secondary: Activated T cell count at Week 24 and Week 52

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    End point title
    		 Activated T cell count at Week 24 and Week 52
    End point description
    A T cell is a type of lymphocyte that plays a central role in cell-mediated immunity. Activated T cell count Codarri is CD4+ CD25hi CD45RA- IL 7Rhi (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [47]
    12
    Units: Conc-cells/mL
    least squares mean (standard error)
        Week 24; n=9, 6
    109279.5 ( 22998.02 )
    78952.7 ( 26155.19 )
        Week 52; n=10, 7
    122304.7 ( 21898.24 )
    75349.4 ( 24313.62 )
    Notes
    [47] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -30326.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -100559.1
         upper limit
    		 39905.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    34677.86
    Statistical analysis title
    		 Statistical anlaysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -46955.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -113218.9
         upper limit
    		 19308.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    32594.81

    Secondary: Activated T cell percentage at Week 24 and Week 52

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    End point title
    		 Activated T cell percentage at Week 24 and Week 52
    End point description
    Activated T cell percentage (Codarri)= CD4+ CD25hi CD45RA- IL 7Rhi (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [48]
    12
    Units: Percentage of activated T cell
    least squares mean (standard error)
        Week 24; n=9, 6
    17 ( 2.29 )
    14 ( 2.58 )
        Week 52; n=10, 7
    15.2 ( 2.15 )
    14.7 ( 2.33 )
    Notes
    [48] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -10.1
         upper limit
    		 4.2
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.54
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.4
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -7.2
         upper limit
    		 6.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    3.35

    Secondary: Regulatory T cell count at Week 24 and Week 52

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    End point title
    		 Regulatory T cell count at Week 24 and Week 52
    End point description
    Regulatory T cell count is CD4+ CD25hi IL-7Rlo (Conc-cells/mL). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [49]
    12
    Units: Conc-cells/mL
    least squares mean (standard error)
        Week 24; n= 9, 7
    23586.2 ( 8427.77 )
    24234.5 ( 9238.41 )
        Week 52; n= 10, 8
    33038.7 ( 7676.99 )
    27419.8 ( 9093.84 )
    Notes
    [49] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    648.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24661.1
         upper limit
    		 25957.7
    Variability estimate
    Standard error of the mean
    Dispersion value
    12618.44
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -5618.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -29994.8
         upper limit
    		 18757
    Variability estimate
    Standard error of the mean
    Dispersion value
    12153.03

    Secondary: Regulatory T cell (%CD4) at Week 24 and Week 52

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    End point title
    		 Regulatory T cell (%CD4) at Week 24 and Week 52
    End point description
    Regulatory T cell (%CD4) = CD4+ CD25hi IL-7Rlo (% of CD4+). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [50]
    12
    Units: Percentage of Regulatory T cell
    least squares mean (standard error)
        Week 24; n= 9, 7
    4.4 ( 1.12 )
    4.6 ( 1.25 )
        Week 52; n= 11, 10
    5 ( 1.01 )
    4.4 ( 1.04 )
    Notes
    [50] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.2
         upper limit
    		 3.5
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.67
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.6
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.5
         upper limit
    		 2.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.45

    Secondary: Mean Activated: regulatory T cell ratio at Week 24 and Week 52

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    End point title
    		 Mean Activated: regulatory T cell ratio at Week 24 and Week 52
    End point description
    Activated: regulatory T cell ratio is Activated T cell CD4+CD25hi CD45RA IL 7Rhi (absolute number)/ Regulatory T cell CD4+CD25hi CD45RA IL 7Rlo (absolute number). Adjusted mean difference (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [51]
    12
    Units: Ratio
    least squares mean (standard error)
        Week 24; n= 9, 6
    4.88 ( 0.832 )
    3.33 ( 0.915 )
        Week 52; n= 10, 7
    4.62 ( 0.779 )
    3.61 ( 0.942 )
    Notes
    [51] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.07
         upper limit
    		 0.98
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.255
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -3.68
         upper limit
    		 1.67
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.329

    Secondary: Proportion of participants with episodes of acute rejection at Week 24 and Week 52

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    End point title
    		 Proportion of participants with episodes of acute rejection at Week 24 and Week 52
    End point description
    The endpoint diagnosis was made by a proven biopsy result. Number of rejections only counted once per participant. The proportion of participants with episodes of acute rejection was assessed at Week 24 (at the end of therapy) and at Week 52 (at study end). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [52]
    12
    Units: Participants
        Week 24; n=5, 6
    2
    2
        Week 52; n=5, 6
    3
    2
    Notes
    [52] - mITT Population. Participants analyzed had at least one biopsy.
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Proportion
    Point estimate
    -0.067
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.638
         upper limit
    		 0.505
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Difference in Proportion
    Point estimate
    -0.267
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.838
         upper limit
    		 0.305

    Secondary: Mean Serum Creatinine at Week 24 and Week 52

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    End point title
    		 Mean Serum Creatinine at Week 24 and Week 52
    End point description
    Adjusted mean difference for serum creatinine values (treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction, at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [53]
    12
    Units: micromole/L
    least squares mean (standard error)
        Week 24; n=9, 7
    115.1 ( 35.24 )
    112.3 ( 38.2 )
        Week 52; n= 10, 10
    135.4 ( 33.5 )
    122.6 ( 33.37 )
    Notes
    [53] - mITT Population
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -107.1
         upper limit
    		 81.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    47.52
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -105.9
         upper limit
    		 100.3
    Variability estimate
    Standard error of the mean
    Dispersion value
    52.06

    Secondary: Mean eGFR at Week 24 and Week 52

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    End point title
    		 Mean eGFR at Week 24 and Week 52
    End point description
    The estimated glomerular filtration rate (eGFR) were calculated by the abbreviated Modification of Diet in Renal Disease (MDRD) equation. Adjusted mean difference(treatment-placebo) and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24 and Week 52. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at the indicated time points were analyzed (represented by n= X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24 and Week 52
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    13 [54]
    12
    Units: mL/minute/1.73 square meter (m^2)
    least squares mean (standard error)
        Week 24; n=9, 7
    62.25 ( 6.119 )
    49.33 ( 6.897 )
        Week 52; n= 10, 10
    58.99 ( 5.732 )
    56.29 ( 5.765 )
    Notes
    [54] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Week 24 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -12.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.56
         upper limit
    		 5.71
    Variability estimate
    Standard error of the mean
    Dispersion value
    9.44
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Week 52 comparison
    Comparison groups
    Belimumab 10mg/kg v Placebo
    Number of subjects included in analysis
    25
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.11
         upper limit
    		 13.72
    Variability estimate
    Standard error of the mean
    Dispersion value
    8.315

    Secondary: Mean Prednisolone use at Week 24

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    End point title
    		 Mean Prednisolone use at Week 24
    End point description
    Adjusted mean difference (treatment-placebo) for Prednisolone use and 95% confidence intervals for differences were obtained from MMRM model, with fixed categorical effects of treatment, visit, donor type and treatment-by-visit interaction and fixed continuous covariates of Baseline and Baseline-by-visit interaction at Week 24. A compound symmetry variance structure was used to model the within-participant errors, shared across treatments. Only those participants available at indicated timepoints were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Placebo Belimumab 10mg/kg
    Number of subjects analysed
    10 [55]
    7
    Units: mg/day
        least squares mean (standard error)
    5.71 ( 1.438 )
    5.27 ( 1.713 )
    Notes
    [55] - mITT Population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    Placebo v Belimumab 10mg/kg
    Number of subjects included in analysis
    17
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.84
         upper limit
    		 3.96
    Variability estimate
    Standard error of the mean
    Dispersion value
    2.225

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of study medication until follow-up (up to 52 weeks).
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for MITT Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Belimumab 10mg/kg
    Reporting group description
    		 Participants received 10 mg /kg belimumab in 250 mL normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.

    Serious adverse events
    		 Belimumab 10mg/kg Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    5 / 12 (41.67%)
    7 / 13 (53.85%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Cardiac failure acute
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Transplant rejection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary oedema
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Glomerulonephritis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Clostridium difficile colitis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cyst infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tonsillitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urosepsis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Belimumab 10mg/kg Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 12 (75.00%)
    9 / 13 (69.23%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Respiratory disorder
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Polyomavirus test positive
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Cytomegalovirus test positive
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Epstein-Barr virus test positive
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Injury, poisoning and procedural complications
    Hip fracture
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Tachycardia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Migraine
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Paraesthesia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Tremor
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Leukopenia
         subjects affected / exposed
    4 / 12 (33.33%)
    4 / 13 (30.77%)
         occurrences all number
    4
    4
    Anaemia
         subjects affected / exposed
    2 / 12 (16.67%)
    3 / 13 (23.08%)
         occurrences all number
    2
    3
    Anaemia vitamin B12 deficiency
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Iron deficiency anaemia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Polycythaemia
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Thrombocytopenia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    5 / 12 (41.67%)
    3 / 13 (23.08%)
         occurrences all number
    6
    3
    Dyspepsia
         subjects affected / exposed
    2 / 12 (16.67%)
    2 / 13 (15.38%)
         occurrences all number
    2
    2
    Oesophagitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Vomiting
         subjects affected / exposed
    2 / 12 (16.67%)
    0 / 13 (0.00%)
         occurrences all number
    2
    0
    Duodenal ulcer
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Duodenitis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Mouth ulceration
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Ulcerative gastritis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Cold sweat
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Hyperhidrosis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Vasculitic rash
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Renal artery stenosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 12 (33.33%)
    2 / 13 (15.38%)
         occurrences all number
    4
    3
    Lower respiratory tract infection
         subjects affected / exposed
    2 / 12 (16.67%)
    1 / 13 (7.69%)
         occurrences all number
    2
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 12 (8.33%)
    2 / 13 (15.38%)
         occurrences all number
    1
    2
    Tonsillitis
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Wound infection
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1
    Onychomycosis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Oral candidiasis
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Pneumonia
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Polyomavirus-associated nephropathy
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Renal cyst infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 13 (7.69%)
         occurrences all number
    0
    1
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Vulvovaginal candidiasis
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 13 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 12 (8.33%)
    1 / 13 (7.69%)
         occurrences all number
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Apr 2013
    The protocol has been amended to provide clarification that this study is not powered to detect clinical efficacy endpoints, and that there is a strong focus on biomarker endpoints to help determine the potential for efficacy. The study objectives have been reworded to reflect a greater emphasis on defining pharmacodynamic responses with belimumab and understanding the impact of belimumab on biomarkers in order to provide a clear assessment of potential for clinical efficacy with belimumab. Endpoints and analysis sections and the Time and Events table have been updated accordingly.
    01 Jul 2013
    The protocol has been amended to provide clarification of the randomisation strategy and to update sponsor team contact details.
    04 Sep 2013
    The protocol has been amended to provide clarification of timings of study events, correction of safety statement, addition of information from IB update and typographic errors have been addressed.
    16 Oct 2013
    The protocol has been amended to change the eligibility criteria of the donor kidney.
    19 May 2014
    The protocol has been amended to update safety information and to include additional sites. Changes have been made to the endpoints, infusion times on Day 0 and the randomization procedure. Clarity is provided surrounding the number enrolled and randomized to achieve 20 completed subjects. Reference to a supplement has been added which has been issued for the current IB. Changes have been made to the statistical analysis section to ensure consistency with the endpoint section and the primary analysis has been clarified.
    21 Jul 2015
    The protocol has been amended to remove the planned interim data analysis (programming and statistical analysis) of the data up to and including week 24. Analysis of all data will now be undertaken following the week 52 time point (end of study).

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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