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    Clinical Trial Results:
    A Phase II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous IdeS after Administration of Ascending Doses in Chronic Kidney Disease Patients

    Summary
    EudraCT number
    		 2013-005417-13
    Trial protocol
    		 SE  
    Global end of trial date
    13 Feb 2015

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 May 2019
    First version publication date
    18 Apr 2019
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Removed attached appendices.

    Trial information

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    Trial identification
    Sponsor protocol code
    13-HMedIdeS-02
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02224820
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hansa Biopharma AB
    Sponsor organisation address
    Scheelevägen 22, Lund, Sweden, 223 63
    Public contact
    Clinical Trials Information, Hansa Biopharma AB, clinicalstudyinfo@hansabiopharma.com
    Scientific contact
    Clinical Trials Information, Hansa Biopharma AB, clinicalstudyinfo@hansabiopharma.com
    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
    25 Jun 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 Feb 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To find an IdeS dosing scheme which in the majority of the patients results in HLA antibody levels which are acceptable for transplantation. This will be measured as an MFI less than 1100 as measured in a single antigen bead (SAB) assay, within 24 hours from dosing
    Protection of trial subjects
    Dosing was staggered with at least 7 days between patients in the group. The investigator decided the number of doses for each patient (max 2) and the decision was based on both safety and efficacy. There were to be at least 14 days between dosing of the first patient in a higher dose group and dosing of the last patient in the previous dose group. Dose escalation to a higher group was to be based on safety and efficacy evaluation of previous dose groups. Proceeding to a higher dose group always required that the previous full group (2-4 patients) was evaluated by the Data Monitoring Committee (DMC).
    Background therapy
    		 Patients were premedicated with the corticosteroid methylprednisolone (Solu-Medrol®) and the antihistamine loratadine (Loratadin®) before IdeS infusions. All patients received prophylactic antibiotics until their serum total IgG was 3 g/L or more.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Jun 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Sweden: 8
    Worldwide total number of subjects
    8
    EEA total number of subjects
    8
    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)
    7
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed at Uppsala University Hospital in Sweden. Enrolled patients were diagnosed with Chronic Kidney Disease in dialysis and on the waiting list for a kidney transplant. Patients were recruited between 10-Jun-2014 and 12-Dec-2014.

    Pre-assignment
    Screening details
    		 In total, 10 patients were assessed for eligibility. Eight (8) patients were enrolled and started treatment.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group 1
    Arm description
    		 0.12 mg/kg of IdeS once or twice within 48 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    IdeS
    Investigational medicinal product code
    IdeS
    Other name
    HMedIdeS, IgG endopeptidase
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.12 mg/kg milligram(s)/kilogram intravenously once or twice within 48 hours

    Arm title
    		 Group 2
    Arm description
    		 0.25 mg/kg IdeS once or twice within 48 hours
    Arm type
    		 Experimental

    Investigational medicinal product name
    IdeS
    Investigational medicinal product code
    IdeS
    Other name
    HMedIdeS, IgG endopeptidase
    Pharmaceutical forms
    Concentrate and solvent for concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    0.25 mg/kg milligram(s)/kilogram intravenously once or twice within 48 hours

    Number of subjects in period 1
    		Group 1 Group 2
    Started
    3
    5
    Completed
    3
    4
    Not completed
    0
    1
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 8 8
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn - gestational age < 37 wk
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days - 23 months)
    		 0 0
        Children (2 - 11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 7 7
        From 65 to 84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 50.5 ( 11.9 ) -
    Gender categorical
    Units: Subjects
        Male
    		 3 3
        Female
    		 5 5
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    		 74.5 ( 14.5 ) -
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 172.3 ( 9.7 ) -
    Subject analysis sets

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAS) included all patients that received any amount of study medication.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consisted of all patients in the safety analysis set (SAS) who had a measurement of anti-HLA antibody level within 24 hours from dosing. The FAS was used for presenting efficacy data.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol set (PPS) was intended to consist of all patients who received at least one dose of IdeS and had evaluable PK data, and was determined by the PK analyst. The full criteria for the PPS, regarding protocol deviations that warranted exclusions, was specified when all data on protocol violations/deviations were available. The PPS was used for the pharmacokinetics (PK) and pharmacodyamics (PD) evaluations.

    Subject analysis sets values
    		 SAS FAS PPS
    Number of subjects
    8
    8
    7
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn - gestational age < 37 wk
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days - 23 months)
    0
    0
    0
        Children (2 - 11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    7
    7
    6
        From 65 to 84 years
    1
    1
    1
        85 years and over
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    50.5 ( 11.9 )
    50.5 ( 11.9 )
    51.1 ( 12.7 )
    Gender categorical
    Units: Subjects
        Male
    3
    3
    3
        Female
    5
    5
    4
    Weight
    Units: kilogram(s)
        arithmetic mean (standard deviation)
    74.5 ( 14.5 )
    74.5 ( 14.5 )
    71.4 ( 12.5 )
    Height
    Units: cm
        arithmetic mean (standard deviation)
    172.3 ( 9.7 )
    172.3 ( 9.7 )
    172.7 ( 10.4 )

    End points

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    End points reporting groups
    Reporting group title
    Group 1
    Reporting group description
    		 0.12 mg/kg of IdeS once or twice within 48 hours

    Reporting group title
    Group 2
    Reporting group description
    		 0.25 mg/kg IdeS once or twice within 48 hours

    Subject analysis set title
    SAS
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The safety analysis set (SAS) included all patients that received any amount of study medication.

    Subject analysis set title
    FAS
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The full analysis set (FAS) consisted of all patients in the safety analysis set (SAS) who had a measurement of anti-HLA antibody level within 24 hours from dosing. The FAS was used for presenting efficacy data.

    Subject analysis set title
    PPS
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    The per protocol set (PPS) was intended to consist of all patients who received at least one dose of IdeS and had evaluable PK data, and was determined by the PK analyst. The full criteria for the PPS, regarding protocol deviations that warranted exclusions, was specified when all data on protocol violations/deviations were available. The PPS was used for the pharmacokinetics (PK) and pharmacodyamics (PD) evaluations.

    Primary: Mean fluorescent intensity of less than 1100 within 24 hours

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    End point title
    		 Mean fluorescent intensity of less than 1100 within 24 hours [1]
    End point description
    The primary endpoint in the study was efficacy defined as the IdeS dosing scheme resulting in HLA antibody levels acceptable for transplantation. It was analyzed using serial analysis for antibodies. Results from the single antigen bead (SAB) HLA assay were combined with results from the complement fixating anti-HLA assay (C1q). The acceptance criterion for transplantation was defined as a mean fluorescence intensity (MFI) of <1100, within 24 h from dosing. A responder was defined as a patient for whom all pre-dose MFI values that were >1100 had the 90th percentile MFI <1100 within 24 h after IdeS treatment.
    End point type
    Primary
    End point timeframe
    From IdeS dosing up to 24 h after IdeS administration: (i) single antigen bead (SAB) HLA: pre-dose, 1h, 2h, 6h, and 24h post-dose (ii) complementing fixating anti-HLA assay (C1q): pre-dose, 1h and 24 h post-dose
    Notes
    [1] - 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: 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. Either resolve this issue or provide a justification.
    End point values
    		 Group 1 Group 2 FAS
    Number of subjects analysed
    3
    5 [2]
    8 [3]
    Units: Number of responders
        SAB HLA
    0
    3
    3
        C1q
    3
    3
    6
    Notes
    [2] - The C1q analysis íncluded 3 patients only due to high background for 1 p and dose interrupted for 1p
    [3] - The C1q analysis íncluded 6 patients only due to high background for 1 p and dose interrupted for 1p
    No statistical analyses for this end point

    Secondary: Safety

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    End point title
    		 Safety
    End point description
    A summary of repored Adverse Events (AE)s from the study is included. Please refer to the "Adverse Event" section for details on the specific AEs reported from this clinical study.
    End point type
    Secondary
    End point timeframe
    AEs were collected from the time-point the patient was admitted to the clinical trial unit and throughout the study including the follow-up period (i.e. up to day 64).
    End point values
    		 Group 1 Group 2 SAS
    Number of subjects analysed
    3
    5
    8
    Units: Number of AEs
        Adverse Events
    23
    53
    76
        Related Adverse Events
    8
    19
    27
        Serious Adverse Events
    1
    4
    5
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: Cmax

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    End point title
    		 PK profile of IdeS: Cmax
    End point description
    Cmax = Maximum observed plasma concentration of IdeS following dosing (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    3
    4
    Units: µg/mL
        arithmetic mean (standard deviation)
    2.24 ( 0.08 )
    6.39 ( 1.02 )
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: tmax

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    End point title
    		 PK profile of IdeS: tmax
    End point description
    Tmax = Time of occurrence of Cmax (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    3
    4
    Units: hour
        arithmetic mean (standard deviation)
    0.92 ( 0.93 )
    0.94 ( 0.77 )
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: AUC

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    End point title
    		 PK profile of IdeS: AUC
    End point description
    AUC = Area under the plasma concentration vs time curve from time 0 to infinity (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to day 21
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    3
    4
    Units: h x µg/mL
        arithmetic mean (standard deviation)
    110 ( 27 )
    487 ( 30 )
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: t1/2

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    End point title
    		 PK profile of IdeS: t1/2
    End point description
    t1/2 = Terminal half-life (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Up to day 21
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4
    7
    Units: hour
        arithmetic mean (standard deviation)
    54 ( 7 )
    135 ( 111 )
    100 ( 90 )
    No statistical analyses for this end point

    Secondary: PK Profile of IdeS: CL

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    End point title
    		 PK Profile of IdeS: CL
    End point description
    CL = Clearance (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4
    7
    Units: mL/h/Kg
        arithmetic mean (standard deviation)
    1.14 ( 0.32 )
    0.66 ( 0.33 )
    0.86 ( 0.39 )
    No statistical analyses for this end point

    Secondary: PK Profile of IdeS: Vz

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    End point title
    		 PK Profile of IdeS: Vz
    End point description
    Vz = Volume of distribution during the elimination phase (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately berfore IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4
    7
    Units: L/kg
        arithmetic mean (standard deviation)
    0.088 ( 0.015 )
    0.092 ( 0.019 )
    0.090 ( 0.016 )
    No statistical analyses for this end point

    Secondary: PD Profile of IdeS: Cleavage of IgG

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    End point title
    		 PD Profile of IdeS: Cleavage of IgG
    End point description
    The efficacy of IdeS treatment on IgG was investigated using an enzyme-linked immunosorbent assay (ELISA) at different time-points after dosing. This assay determines the sum of intact IgG and single chain cleaved IgG (scIgG) in serum. In addition a turbimetirc assay and a qualitative sodium dodecyl sulfate polyacrylamide gel electrophoresis (SDS-PAGE) analysis were done (results not included). The mean concentration of IgG at selected timepoints after dosing is presented to follow the progress of the IgG cleaving process. Individual IgG concentrations at all time-points are listed in Appendix 16.2, List 16.2.6.7.
    End point type
    Secondary
    End point timeframe
    1 dose: pre-dose, 14min, 0.5, 1, 2, 4, 6, 8, 24, 48, 72h, 7, 14, 21, 28, and 64d after dosing 2 doses: 1st dose as above until 24h, then pre-2nd dose, 14min, 0.5, 1, 2, 4, 6, 8, 24, 48, 72h, 7, 14, 21, 28, and 64d after dosing
    End point values
    		 Group 1 Group 2
    Number of subjects analysed
    3
    4 [4]
    Units: microgram(s)/millilitre
    arithmetic mean (full range (min-max))
        Concentration pre-1st dose
    11000 (6800 to 13800)
    9300 (7900 to 10700)
        Concentration at 6h (1st dose)
    2200 (1000 to 4100)
    130 (37 to 300)
        Concentration at 24h (1st dose)
    610 (350 to 940)
    23 (5 to 41)
        Concentration at 6h (2nd dose)
    43 (14 to 58)
    13 (5 to 25)
        Concentration at 24 h (2nd dose)
    21 (14 to 26)
    5 (5 to 5)
    Notes
    [4] - Please observe that 2 patients only received 2 doses
    No statistical analyses for this end point

    Secondary: Immunogencity of IdeS: Anti-drug antibodies (ADAs)

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    End point title
    		 Immunogencity of IdeS: Anti-drug antibodies (ADAs)
    End point description
    The serum concentration of ant-IdeS IgG was measured. The number of patients with anti-IdeS IgG present at screening and 64 days after IdeS dosing are presented together with the number of patients that had a peak concentration of anti-IdeS IgG lon day 14 after dosing. Individual anti-IdeS IgG concentrations at all sampling time-points are listed in Appendix 16.2, List 16.2.6.6.
    End point type
    Secondary
    End point timeframe
    1 dose: Screening, pre-dose, 24h after dose, 5d, 7d, 14d, 21d, 28d, and 64 d after dose 2 doses: Screening, pre-dose, 24h after 1st dose, 24 h after 2nd dose, 5d, 7d, 14d, 21d, 28d, and 64d after dose
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4
    7
    Units: Number of patients
        ADAs at Screening
    3
    4
    7
        ADAs at Day 64
    3
    4
    7
        Peak concentration of ADAs at Day 14
    2
    4
    6
    No statistical analyses for this end point

    Secondary: Reduction of PRA levels in cytotoxic sera screen after IdeS treatment

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    End point title
    		 Reduction of PRA levels in cytotoxic sera screen after IdeS treatment
    End point description
    Samples were analyzed for complement dependent cytotoxicity (CDC) against a panel of T- and B-cells to determine the level of panel reactivity (PRA) in percentage (%). Number of patients with a reduction in T/B PRA (%) 1 hour after IdeS dosing is presented.
    End point type
    Secondary
    End point timeframe
    1 dose: pre-dose, 1h, 2h, 6h, 24h, 7d, 14d, 28d, and 64d after dosing 2 doses: pre-dose, 1h, 2h, 6h, 24hafter first dose, then 1h, 2h, 6h, 24h, 7d, 14d, 28d, and 64d after second dosing
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4 [5]
    7 [6]
    Units: Number of patients
        Reduced T/B PRA 1 h after 1st dose
    3
    4
    7
        Reduced T/B PRA 1 h after 2nd dose
    3
    2
    5
    Notes
    [5] - Please note that 2 patients only had 2 doses of IdeS
    [6] - Please note that 5 patients only had 2 doses of IdeS
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: Alpha t1/2 and Beta t1/2

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    End point title
    		 PK profile of IdeS: Alpha t1/2 and Beta t1/2
    End point description
    2-compartment analysis Alpha t1/2 = half-life for the distribution phase Beta t1/2 = half-life for the elimination phase Harmonic mean values were calculated for alpha and beta half-lives as ln2/mean alpha and ln2/mean beta, respectively.
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3 [7]
    4 [8]
    7 [9]
    Units: hour
    arithmetic mean (full range (min-max))
        Alpha t1/2
    4.03 (2.38 to 7.77)
    6.26 (3.22 to 11.2)
    5.06 (2.38 to 11.2)
        Beta t1/2
    53.7 (47.2 to 59.8)
    88.9 (49.2 to 301)
    69.3 (47.2 to 301)
    Notes
    [7] - Harmonic means are presented rather than arithmetic means
    [8] - Harmonic means are presented rather than arithmetic means
    [9] - Harmonic means are presented rather than arithmetic means
    No statistical analyses for this end point

    Secondary: PK profile of IdeS: Vss

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    End point title
    		 PK profile of IdeS: Vss
    End point description
    Vss = Volume of distribution during steady state (non-compartmental analysis)
    End point type
    Secondary
    End point timeframe
    Immediately before IdeS dosing up to 21 days
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    3
    4
    7
    Units: L/kg
        arithmetic mean (standard deviation)
    0.083 ( 0.014 )
    0.084 ( 0.019 )
    0.083 ( 0.015 )
    No statistical analyses for this end point

    Secondary: Results in FACS crossmatch test against available donor cells

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    End point title
    		 Results in FACS crossmatch test against available donor cells
    End point description
    Samples were analyzed for reactivity against T and B lymphocytes from available donors using flow-cytometry. FACS crossmatch test was performed only for the one patient that was kidney transplanted during the course of the study.
    End point type
    Secondary
    End point timeframe
    6h and 24h after each dose of IdeS
    End point values
    		 Group 1 Group 2 PPS
    Number of subjects analysed
    1 [10]
    0 [11]
    1 [12]
    Units: Number of patients
        Positive T and B crossmatch 6h after 1st dose
    1
    1
        Negative T and B crossmatch 6h after 1st dose
    0
    0
        Positive T and B crossmatch 24h after 1st dose
    1
    1
        Negative T and B crossmatch 24h after 1st dose
    0
    0
        Positive T and B crossmatch 6h after 2nd dose
    0
    0
        Negative T and B crossmatch 6h after 2nd dose
    1
    1
        Positive T and B crossmatch 24h after 2nd dose
    0
    0
        Negative T and B crossmatch 24h after 2nd dose
    1
    1
    Notes
    [10] - 1 patient only was transplanted. There were no available donor cells for the other patients.
    [11] - There were no available donor cells for the other patients.
    [12] - 1 patient only was transplanted. There were no available donor cells for the other patients.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From the time of admission until last visit, 64 days after treatment
    Adverse event reporting additional description
    Adverse events included all clinical laboratory tests, vital signs and ECGs jugded as clinically significant.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Group 2
    Reporting group description
    		 0.25 mg/kg IdeS once or twice in 48 hours

    Reporting group title
    Group 1
    Reporting group description
    		 0.12 mg/kg IdeS once or twice within 48 hours

    Reporting group title
    Safety analysis set
    Reporting group description
    		 The safety analysis set (SAS) included all patients that received any amount of study medication.

    Serious adverse events
    		 Group 2 Group 1 Safety analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 5 (60.00%)
    1 / 3 (33.33%)
    4 / 8 (50.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Increased bronchial secretion
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences causally related to treatment / all
    1 / 1
    1 / 1
    2 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Group 2 Group 1 Safety analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 5 (100.00%)
    3 / 3 (100.00%)
    8 / 8 (100.00%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Haematoma
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Hypertension
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Thrombosis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Feeling cold
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Feeling hot
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Infusion site pain
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    2
    Pyrexia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Anxiety
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    1
    1
    Insomnia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Aspartate aminotransferas increased
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    2
    1
    3
    Blood phosphorus increased
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    C-reactive protein increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Donor specific antibody present
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Weight increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Injury, poisoning and procedural complications
    Fall
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Infusion related reaction
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Sinus tachycardia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Nervous system disorders
    Dizziness postural
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    2
    0
    2
    Headache
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    2
    1
    3
    Dysgeuisa
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Tremor
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Leucocytosis
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Leukopenia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Eye disorders
    Scleral haemorrhage
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Visual impairment
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    0 / 5 (0.00%)
    2 / 3 (66.67%)
    2 / 8 (25.00%)
         occurrences all number
    0
    2
    2
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Dyspepsia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Nausea
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Vomiting
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Infections and infestations
    Herpex simplex infection
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Clostridium difficile infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Hordeolum
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1
    Influenza
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    1
    1
    2
    Oral candidas
         subjects affected / exposed
    2 / 5 (40.00%)
    0 / 3 (0.00%)
    2 / 8 (25.00%)
         occurrences all number
    2
    0
    2
    Tonsillitis
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Metabolism and nutrition disorders
    Hyponatraemia
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 5 (20.00%)
    1 / 3 (33.33%)
    2 / 8 (25.00%)
         occurrences all number
    2
    2
    4
    Iron deficiency
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    1 / 8 (12.50%)
         occurrences all number
    1
    0
    1
    Hyperglycaemia
         subjects affected / exposed
    0 / 5 (0.00%)
    1 / 3 (33.33%)
    1 / 8 (12.50%)
         occurrences all number
    0
    1
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/28767349
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