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    Clinical Trial Results:
    A randomised, open-label, multicenter trial to determine safety and efficacy of eculizumab in the prevention of Antibody-Mediated Rejection (AMR) in living donor kidney transplant recipients requiring desensitisation therapy

    Summary
    EudraCT number
    		 2010-019630-28
    Trial protocol
    		 GB   DE   NO   NL   ES   IT   SE  
    Global end of trial date
    13 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2017
    First version publication date
    17 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    C10-001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01399593
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Alexion Pharmaceuticals Inc
    Sponsor organisation address
    100 College Street, New Haven, United States, CT 06510
    Public contact
    European Clinical Trial Information, ALEXION EUROPE SAS, + 33 1 47 10 06 06, clinicaltrials.eu@alexion.com
    Scientific contact
    European Clinical Trial Information, ALEXION EUROPE SAS, + 33 1 47 10 06 06, clinicaltrials.eu@alexion.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
    13 Jul 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Nov 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of this study was to evaluate the safety and efficacy of eculizumab to prevent AMR in sensitised recipients of living donor kidney transplants requiring desensitisation therapy prior to transplantation. The primary endpoint focused on acute AMR during the first 9 weeks post-transplantation.
    Protection of trial subjects
    Vaccination against N. meningitidis at least 14 days prior to study drug initiation and revaccination 30 days later. If not vaccinated 14 days prior, prophylactic antibiotics must have been administered. A booster dose was to be administered 30 days after the initial dose. Pre-transplant infectious disease assessment was performed as part of the screening assessment.
    Background therapy
    		 Patients were to undergo desensitisation therapy according to the practice of the local transplant center prior to transplantation, and this desensitisation practice was to be uniformly applied for all patients at that center throughout the study. The actual length of desensitisation for an individual patient was based on the clinical judgment of the Transplant Center team. Rituximab was prohibited in all patients as part of the pre-transplantation desensitisation therapy due to potential pharmacodynamic interactions.
    Evidence for comparator
    		 The control group was designed to test eculizumab against the best available care (referred to as standard of care, or SOC) consisting of plasmapheresis (PP) and/or intravenous immunoglobulin (IVIg). The best available care consisting of PP and IVIg was chosen because these modalities combined represented the most prevalent therapy reported in the literature and were the best available therapies at the time of this protocol’s inception as per the transplant community.
    Actual start date of recruitment
    02 Nov 2011
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Safety
    Long term follow-up duration
    		 36 Months
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Norway: 2
    Country: Number of subjects enrolled
    Spain: 7
    Country: Number of subjects enrolled
    Sweden: 5
    Country: Number of subjects enrolled
    United Kingdom: 15
    Country: Number of subjects enrolled
    France: 10
    Country: Number of subjects enrolled
    Germany: 2
    Country: Number of subjects enrolled
    Italy: 6
    Country: Number of subjects enrolled
    Australia: 5
    Country: Number of subjects enrolled
    United States: 47
    Worldwide total number of subjects
    102
    EEA total number of subjects
    50
    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)
    96
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment period lasted from Nov 2011 to Mar 2014. Forty-one sites in Australia, the European Union, and North America participated in this study.

    Pre-assignment
    Screening details
    		 Screening lasted approximately 8 wks. Written consent was provided prior to performing any study-required assessments. Patients who met screening criteria were enrolled and underwent desensitisation therapy prior to transplantation, according to local transplant center practice.

    Pre-assignment period milestones
    Number of subjects started
    		 275 [1]
    Intermediate milestone: Number of subjects
    Passed screening: 137
    Intermediate milestone: Number of subjects
    Randomised: 104
    Number of subjects completed
    		 102

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Adverse event, non-fatal: 7
    Reason: Number of subjects
    		 Adverse event, serious fatal: 1
    Reason: Number of subjects
    		 Consent withdrawn by subject: 4
    Reason: Number of subjects
    		 Physician decision: 13
    Reason: Number of subjects
    		 Enrolment failure: 3
    Reason: Number of subjects
    		 Donor or pre-transplantation logistical issues: 62
    Reason: Number of subjects
    		 Did not meet inclusion/exclusion criteria: 62
    Reason: Number of subjects
    		 Failed desensitisation: 18
    Reason: Number of subjects
    		 Randomised but not transplanted: 2
    Reason: Number of subjects
    		 Passed screening in error: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 275 patients were screened; among them, 102 patients were randomised and transplanted, and received eculizumab or standard of care for up to 9 weeks post-transplantation.
    Period 1
    Period 1 title
    9-wk treatment and 60-day washout (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was an open-label study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Eculizumab treatment group
    Arm description
    		 Patients in the eculizumab treatment group were to receive eculizumab starting approximately 1 hour prior to reperfusion of the allograft and then received a set regimen of dosing for 9 weeks post transplantation, as described in the "Dosage and administration details" section. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment with eculizumab plus an additional 60-day washout period.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eculizumab
    Investigational medicinal product code
    eculizumab
    Other name
    Soliris
    Pharmaceutical forms
    Concentrate for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Eculizumab was administered for 9 weeks according to the following dosing regimen: Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously, with median infusion time of 39 minutes.

    Arm title
    		 SOC treatment group
    Arm description
    		 Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of PP and IVIg. Patients randomised to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomised to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase.
    Arm type
    		 Best available care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Eculizumab treatment group SOC treatment group
    Started
    51
    51
    Completed
    48
    49
    Not completed
    3
    2
         Adverse event, serious fatal
    1
    1
         Physician decision
    1
    -
         Adverse event, non-fatal
    1
    -
         Transplantectomy
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Eculizumab treatment group
    Reporting group description
    		 Patients in the eculizumab treatment group were to receive eculizumab starting approximately 1 hour prior to reperfusion of the allograft and then received a set regimen of dosing for 9 weeks post transplantation, as described in the "Dosage and administration details" section. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment with eculizumab plus an additional 60-day washout period.

    Reporting group title
    SOC treatment group
    Reporting group description
    		 Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of PP and IVIg. Patients randomised to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomised to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase.

    Reporting group values
    		 Eculizumab treatment group SOC treatment group Total
    Number of subjects
    		 51 51 102
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 47 49 96
        From 65-84 years
    		 4 2 6
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 37 30 67
        Male
    		 14 21 35
    Race
    Units: Subjects
        White
    		 37 36 73
        Asian
    		 2 3 5
        Black or African American
    		 6 6 12
        Other
    		 6 6 12
    Total DSA
    Units: MFI
        arithmetic mean (standard deviation)
    		 15394.7 ( 14163.78 ) 17469.8 ( 12573.44 ) -
    Highest Single DSA
    Units: MFI
        arithmetic mean (standard deviation)
    		 8135 ( 4048.08 ) 8740.7 ( 4289.97 ) -

    End points

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    End points reporting groups
    Reporting group title
    Eculizumab treatment group
    Reporting group description
    		 Patients in the eculizumab treatment group were to receive eculizumab starting approximately 1 hour prior to reperfusion of the allograft and then received a set regimen of dosing for 9 weeks post transplantation, as described in the "Dosage and administration details" section. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment with eculizumab plus an additional 60-day washout period.

    Reporting group title
    SOC treatment group
    Reporting group description
    		 Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of PP and IVIg. Patients randomised to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. Data reported are summarised for the "Prevention phase" of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomised to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase.

    Primary: Treatment failure rate

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    End point title
    		 Treatment failure rate
    End point description
    The primary efficacy endpoint was treatment failure rate, a composite endpoint defined as the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up measured through 9 weeks post-transplantation.
    End point type
    Primary
    End point timeframe
    9 weeks post-transplantation
    End point values
    		 Eculizumab treatment group SOC treatment group
    Number of subjects analysed
    51
    51
    Units: Number of patients
        Treatment failure rate
    5
    7
        Acute AMR
    5
    5
        Graft loss
    0
    3
        Death
    1
    1
        Loss to follow-up
    0
    2
    Statistical analysis title
    		 Statistical analysis 1 for treatment failure rate
    Statistical analysis description
    The analysis was based on full analysis set and analysed by randomised treatment.
    Comparison groups
    SOC treatment group v Eculizumab treatment group
    Number of subjects included in analysis
    102
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 = 0.76
    Method
    		 Fisher exact
    Parameter type
    		 Proportion difference
    Point estimate
    -3.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.9
         upper limit
    		 16.3
    Notes
    [1] - The primary efficacy variable was a binary outcome variable where patients meeting the composite endpoint of the occurrence of 1) biopsy-proven acute AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up definition at Week 9 post-transplantation were considered treatment failures and all others were considered treatment successes.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Safety was evaluated for all patients through their duration in the study by randomised treatment and, separately, by actual treatment received.
    Adverse event reporting additional description
    Serious and non-serious adverse events are summarised for the "Prevention Phase" (i.e., first 9 wks of prophylactic treatment post-transplantation and an additional 60 days for washout). Data from the Prevention Phase are considered as the most relevant given that it includes only data from patients under treatment for the prevention of acute AMR.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    SOC treatment group
    Reporting group description
    		 If patient were switched to eculizumab for the treatment of acute AMR, from that point forward their data were no longer included in the Prevention Phase.

    Reporting group title
    Eculizumab treatment group
    Reporting group description
    		 All patients randomised to receive eculizumab during the Prevention Phase.

    Serious adverse events
    		 SOC treatment group Eculizumab treatment group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    38 / 51 (74.51%)
    36 / 51 (70.59%)
         number of deaths (all causes)
    1
    1
         number of deaths resulting from adverse events
    1
    1
    Vascular disorders
    Circulatory collapse
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypovolaemic shock
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lymphocele
         subjects affected / exposed
    5 / 51 (9.80%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Superior vena cava occlusion
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Nephrostomy
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Hypothermia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Impaired healing
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Influenza like illness
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Systemic inflammatory response syndrome
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    18 / 51 (35.29%)
    14 / 51 (27.45%)
         occurrences causally related to treatment / all
    0 / 20
    1 / 15
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug hypersensitivity
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Social circumstances
    Convalescent
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Anti-glomerular basement membrane antibody
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Antibody test positive
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood creatinine increased
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Drug level increased
    Additional description: High Level of Tacrolimus
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Complications of transplanted kidney
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Delayed graft function
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft thrombosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Incisional hernia
         subjects affected / exposed
    0 / 51 (0.00%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Procedural pain
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound dehiscence
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac arrest
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Nervous system disorders
    Cerebellar haemorrhage
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Migraine
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Coagulopathy
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal wall haematoma
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulum
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemorrhoids
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Large intestine perforation
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis acute
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pancreatitis relapsing
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subileus
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    2 / 51 (3.92%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Focal segmental glomerulosclerosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haematuria
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 51 (3.92%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrectasia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nephrotic syndrome
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal injury
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric dilatation
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary incontinence
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myalgia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Abdominal sepsis
    Additional description: Fatality occurred in one patient who experienced both one serious adverse event of abdominal sepsis on Day 16 and one serious adverse event of bacterial sepsis on Day 36.
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bacteraemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacterial sepsis
    Additional description: Fatality occurred in one patient who experienced both one serious adverse event of abdominal sepsis on Day 16 and one serious adverse event of bacterial sepsis on Day 36.
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    1 / 1
    Bronchitis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Device related sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia bacteraemia
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
    2 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemophilus infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metapneumovirus infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    2 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative wound infection
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    1 / 51 (1.96%)
    2 / 51 (3.92%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 51 (1.96%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection enterococcal
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection pseudomonal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary tract infection staphylococcal
         subjects affected / exposed
    0 / 51 (0.00%)
    1 / 51 (1.96%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia viral
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Gout
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoglycaemia
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolic acidosis
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dehydration
         subjects affected / exposed
    1 / 51 (1.96%)
    0 / 51 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 SOC treatment group Eculizumab treatment group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    47 / 51 (92.16%)
    51 / 51 (100.00%)
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Haematoma
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Hypertension
         subjects affected / exposed
    11 / 51 (21.57%)
    11 / 51 (21.57%)
         occurrences all number
    12
    13
    Hypotension
         subjects affected / exposed
    9 / 51 (17.65%)
    6 / 51 (11.76%)
         occurrences all number
    11
    7
    Lymphocele
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    4
    3
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    7 / 51 (13.73%)
    7 / 51 (13.73%)
         occurrences all number
    9
    7
    Chest pain
         subjects affected / exposed
    1 / 51 (1.96%)
    5 / 51 (9.80%)
         occurrences all number
    1
    5
    Oedema
         subjects affected / exposed
    4 / 51 (7.84%)
    5 / 51 (9.80%)
         occurrences all number
    4
    5
    Chills
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    4
    1
    Oedema peripheral
         subjects affected / exposed
    13 / 51 (25.49%)
    9 / 51 (17.65%)
         occurrences all number
    15
    13
    Pain
         subjects affected / exposed
    5 / 51 (9.80%)
    3 / 51 (5.88%)
         occurrences all number
    7
    5
    Pyrexia
         subjects affected / exposed
    11 / 51 (21.57%)
    9 / 51 (17.65%)
         occurrences all number
    12
    12
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    3 / 51 (5.88%)
    5 / 51 (9.80%)
         occurrences all number
    3
    5
    Kidney transplant rejection
         subjects affected / exposed
    7 / 51 (13.73%)
    11 / 51 (21.57%)
         occurrences all number
    7
    12
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 51 (7.84%)
    3 / 51 (5.88%)
         occurrences all number
    4
    3
    Pulmonary oedema
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 51 (1.96%)
    7 / 51 (13.73%)
         occurrences all number
    1
    8
    Insomnia
         subjects affected / exposed
    7 / 51 (13.73%)
    4 / 51 (7.84%)
         occurrences all number
    7
    4
    Investigations
    Antibody test positive
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Blood creatinine increased
         subjects affected / exposed
    10 / 51 (19.61%)
    8 / 51 (15.69%)
         occurrences all number
    10
    10
    Liver function test abnormal
         subjects affected / exposed
    3 / 51 (5.88%)
    6 / 51 (11.76%)
         occurrences all number
    3
    6
    Injury, poisoning and procedural complications
    Incision site pain
         subjects affected / exposed
    6 / 51 (11.76%)
    8 / 51 (15.69%)
         occurrences all number
    6
    10
    Perinephric collection
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Procedural haemorrhage
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Procedural pain
         subjects affected / exposed
    8 / 51 (15.69%)
    7 / 51 (13.73%)
         occurrences all number
    9
    10
    Wound secretion
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    7 / 51 (13.73%)
    5 / 51 (9.80%)
         occurrences all number
    7
    6
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    4 / 51 (7.84%)
    6 / 51 (11.76%)
         occurrences all number
    4
    7
    Headache
         subjects affected / exposed
    2 / 51 (3.92%)
    9 / 51 (17.65%)
         occurrences all number
    3
    12
    Tremor
         subjects affected / exposed
    8 / 51 (15.69%)
    11 / 51 (21.57%)
         occurrences all number
    11
    12
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    24 / 51 (47.06%)
    14 / 51 (27.45%)
         occurrences all number
    31
    20
    Leukopenia
         subjects affected / exposed
    17 / 51 (33.33%)
    12 / 51 (23.53%)
         occurrences all number
    17
    14
    Thrombocytopenia
         subjects affected / exposed
    6 / 51 (11.76%)
    2 / 51 (3.92%)
         occurrences all number
    7
    2
    Hypofibrinogenaemia
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    6 / 51 (11.76%)
    3 / 51 (5.88%)
         occurrences all number
    7
    3
    Constipation
         subjects affected / exposed
    13 / 51 (25.49%)
    12 / 51 (23.53%)
         occurrences all number
    13
    12
    Diarrhoea
         subjects affected / exposed
    15 / 51 (29.41%)
    17 / 51 (33.33%)
         occurrences all number
    19
    24
    Nausea
         subjects affected / exposed
    14 / 51 (27.45%)
    22 / 51 (43.14%)
         occurrences all number
    17
    25
    Vomiting
         subjects affected / exposed
    5 / 51 (9.80%)
    10 / 51 (19.61%)
         occurrences all number
    5
    10
    Gastrooesophageal reflux disease
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Flatulence
         subjects affected / exposed
    3 / 51 (5.88%)
    4 / 51 (7.84%)
         occurrences all number
    3
    4
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Pruritus
         subjects affected / exposed
    9 / 51 (17.65%)
    8 / 51 (15.69%)
         occurrences all number
    10
    8
    Rash
         subjects affected / exposed
    0 / 51 (0.00%)
    3 / 51 (5.88%)
         occurrences all number
    0
    3
    Renal and urinary disorders
    Anuria
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Bladder spasm
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Dysuria
         subjects affected / exposed
    4 / 51 (7.84%)
    2 / 51 (3.92%)
         occurrences all number
    4
    2
    Haematuria
         subjects affected / exposed
    8 / 51 (15.69%)
    5 / 51 (9.80%)
         occurrences all number
    8
    5
    Oliguria
         subjects affected / exposed
    4 / 51 (7.84%)
    0 / 51 (0.00%)
         occurrences all number
    4
    0
    Polyuria
         subjects affected / exposed
    4 / 51 (7.84%)
    4 / 51 (7.84%)
         occurrences all number
    4
    4
    Proteinuria
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Renal impairment
         subjects affected / exposed
    1 / 51 (1.96%)
    3 / 51 (5.88%)
         occurrences all number
    1
    3
    Renal tubular necrosis
         subjects affected / exposed
    3 / 51 (5.88%)
    2 / 51 (3.92%)
         occurrences all number
    3
    2
    Urinary retention
         subjects affected / exposed
    3 / 51 (5.88%)
    1 / 51 (1.96%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    8 / 51 (15.69%)
    5 / 51 (9.80%)
         occurrences all number
    8
    7
    Muscular weakness
         subjects affected / exposed
    3 / 51 (5.88%)
    0 / 51 (0.00%)
         occurrences all number
    3
    0
    Musculoskeletal pain
         subjects affected / exposed
    2 / 51 (3.92%)
    5 / 51 (9.80%)
         occurrences all number
    2
    6
    Infections and infestations
    BK virus infection
         subjects affected / exposed
    2 / 51 (3.92%)
    8 / 51 (15.69%)
         occurrences all number
    2
    9
    Oral candidiasis
         subjects affected / exposed
    1 / 51 (1.96%)
    4 / 51 (7.84%)
         occurrences all number
    1
    4
    Upper respiratory tract infection
         subjects affected / exposed
    2 / 51 (3.92%)
    7 / 51 (13.73%)
         occurrences all number
    2
    7
    Urinary tract infection
         subjects affected / exposed
    12 / 51 (23.53%)
    19 / 51 (37.25%)
         occurrences all number
    15
    27
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 51 (1.96%)
    5 / 51 (9.80%)
         occurrences all number
    1
    5
    Diabetes mellitus
         subjects affected / exposed
    7 / 51 (13.73%)
    4 / 51 (7.84%)
         occurrences all number
    7
    4
    Fluid overload
         subjects affected / exposed
    5 / 51 (9.80%)
    2 / 51 (3.92%)
         occurrences all number
    5
    2
    Hyperglycaemia
         subjects affected / exposed
    11 / 51 (21.57%)
    13 / 51 (25.49%)
         occurrences all number
    11
    14
    Hyperkalaemia
         subjects affected / exposed
    12 / 51 (23.53%)
    7 / 51 (13.73%)
         occurrences all number
    14
    7
    Hyperlipidaemia
         subjects affected / exposed
    0 / 51 (0.00%)
    4 / 51 (7.84%)
         occurrences all number
    0
    4
    Hyperphosphataemia
         subjects affected / exposed
    3 / 51 (5.88%)
    3 / 51 (5.88%)
         occurrences all number
    3
    3
    Hypocalcaemia
         subjects affected / exposed
    10 / 51 (19.61%)
    14 / 51 (27.45%)
         occurrences all number
    11
    15
    Hypokalaemia
         subjects affected / exposed
    8 / 51 (15.69%)
    10 / 51 (19.61%)
         occurrences all number
    8
    11
    Hypomagnesaemia
         subjects affected / exposed
    10 / 51 (19.61%)
    12 / 51 (23.53%)
         occurrences all number
    10
    13
    Hyponatraemia
         subjects affected / exposed
    2 / 51 (3.92%)
    3 / 51 (5.88%)
         occurrences all number
    2
    3
    Hypophosphataemia
         subjects affected / exposed
    9 / 51 (17.65%)
    16 / 51 (31.37%)
         occurrences all number
    9
    16
    Metabolic acidosis
         subjects affected / exposed
    4 / 51 (7.84%)
    8 / 51 (15.69%)
         occurrences all number
    4
    8
    Vitamin D deficiency
         subjects affected / exposed
    4 / 51 (7.84%)
    5 / 51 (9.80%)
         occurrences all number
    4
    5

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    22 Jun 2011
    Changes implemented as part of a first global amendment included: - To specify that randomisation was to be stratified by the pre-transplant desensitisation protocol used - To specify that all patients must have been re-vaccinated according to current medical guidelines for vaccination use - To clarify the use of other therapies in the eculizumab treatment arm - To add a secondary endpoint "Treatment failure rate defined as the occurrence of 1) biopsy-proven AMR, 2) graft loss, 3) patient death, or 4) loss to follow-up at Month 12 post-transplantation
    04 Nov 2011
    Changes implemented as part of a second global amendment included: - To update the enrollment and randomisation screening/enrollment - To update the diagnosis and main criteria for inclusion/exclusion criteria - To specify a maximum of 9 weeks of eculizumab treatment for AMR
    04 May 2012
    Changes implemented as part of the third global amendment included: - To update B and T flow crossmatch levels - To explain the length of time between signing of the informed consent and transplantation (desensitisation) - To explain the timing for patients to receive meningococcal vaccination - To add a section describing eculizumab dosing after treatment with FFP
    11 Feb 2013
    Purpose of fourth global protocol amendment was to: - Update the enrollment criteria. - Revise the cross-match requirements for patient eligibility and desensitization. - Clarify current procedures and explain the reason for the added procedures. - Increased the number of planned patients from 80 to 90, requiring an increase in the number of screened patients from 100 to 130 based on revised statistical analysis

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    13 Nov 2015
    The primary composite endpoint, defined as the occurrence of biopsy-proven AMR, graft loss, patient death, or loss to follow-up at Week 9 post-transplantation, did not reach statistical significance. While the primary composite endpoint rate in the eculizumab treatment group was as expected from earlier studies with eculizumab, the rate in the standard of care treatment group (control group) was lower than was expected, based on natural history studies reported in the literature. Given this, the trial was terminated and no analyses of other efficacy endpoints have been performed. No safety signal has been reported to the Sponsor by the independent data monitoring committee.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Data interpretation confounded by open-label study with potential reporting bias, unequal exposure to randomised prevention therapy between groups, some patients in SOC arm received eculizumab for treatment of AMR, all patients immunosuppressed.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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