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
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EudraCT number |
2011-006215-56 |
Trial protocol |
GB |
Global end of trial date |
08 Feb 2016
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Results information
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Results version number |
v2(current) |
This version publication date |
10 May 2017
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First version publication date |
21 Oct 2016
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Other versions |
v1 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
114424
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford, Middlesex, United Kingdom,
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
09 Jun 2016
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Feb 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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Protection of trial subjects |
Not applicable
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
13 Sep 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
25
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
22
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From 65 to 84 years |
3
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85 years and over |
0
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Recruitment
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Recruitment details |
A total of 30 renal transplant recipients were enrolled, of which 28 were randomized and 25 were transplanted. | |||||||||||||||||||||
Pre-assignment
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Screening details |
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
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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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)
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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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)
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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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
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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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
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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. |
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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.
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End point type |
Primary
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End point timeframe |
Baseline and Week 24
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Notes [1] - Modified Intent to treat (MITT) Population |
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Statistical analysis title |
Statistical analysis 1 | ||||||||||||
Comparison groups |
Belimumab 10mg/kg v Placebo
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Number of subjects included in analysis |
16
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
Method |
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Parameter type |
Mean difference (final values) | ||||||||||||
Point estimate |
-34.4
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Confidence interval |
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level |
95% | ||||||||||||
sides |
2-sided
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lower limit |
-109.5 | ||||||||||||
upper limit |
40.7 | ||||||||||||
Variability estimate |
Standard error of the mean
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Dispersion value |
37.24
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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.
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End point type |
Primary
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End point timeframe |
Up to 1 year
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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. |
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Notes [3] - mITT Population |
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No statistical analyses for this end point |
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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.
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End point type |
Primary
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End point timeframe |
Up to 1 year
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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. |
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Notes [5] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [7] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [9] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [11] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Week 24 and Week 52
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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. |
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Notes [13] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Week 24 and Week 52
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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. |
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Notes [15] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Week 24 and Week 52
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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. |
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Notes [17] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [19] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [21] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [23] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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Notes [25] - mITT Population |
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No statistical analyses for this end point |
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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).
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End point type |
Primary
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End point timeframe |
Baseline, Week 24 and Week 52
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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. |
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|||||||||||||||||||
Notes [27] - mITT Population |
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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. |
|||||||||||||||||||
|
|||||||||||||||||||
Notes [29] - mITT Population |
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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. |
|||||||||||||||||||
|
|||||||||||||||||||
Notes [31] - mITT Population |
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Notes [33] - mITT Population |
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Notes [35] - mITT Population |
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Notes [37] - mITT Population |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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. |
|||||||||||||||||||
|
|||||||||||||||||||
Notes [39] - mITT Population |
|||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||
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. |
|||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||
Notes [41] - mITT Population |
|||||||||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||
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+ cells/mm^3. 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
|
||||||||||||||||||
|
|||||||||||||||||||
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 |
|
|||||||||||||||||||
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 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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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+ (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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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 (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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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 (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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
||||||||||||||||
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
|
|||||||||||||||
|
||||||||||||||||
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 |
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
Notes [53] - 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 |
-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
|
||||||||||||||||||
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
|
|
|||||||||||||||||||
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
|
||||||||||||||||||
|
|||||||||||||||||||
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
|
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
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 information
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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).
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Adverse event reporting additional description |
On-treatment SAEs and non-serious AEs are reported for MITT Population.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.1
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Reporting groups
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Reporting group title |
Placebo
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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
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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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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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. |
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01 Jul 2013 |
The protocol has been amended to provide clarification of the randomisation strategy and to update sponsor team contact details. |
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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. |
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16 Oct 2013 |
The protocol has been amended to change the eligibility criteria of the donor kidney. |
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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. |
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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). |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |