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    Clinical Trial Results:
    A Phase II Randomized, Double-Blind, Placebo-Controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients

    Summary
    EudraCT number
    		 2012-002245-37
    Trial protocol
    		 NO   BE   GB   ES   DE   SE  
    Global end of trial date
    22 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 May 2016
    First version publication date
    07 May 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    GV28418
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01753167
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    F. Hoffmann-La Roche AG
    Sponsor organisation address
    Grenzacherstrasse 124, Basel, Switzerland, CH-4070
    Public contact
    F. Hoffmann-La Roche AG, Roche Trial Information Hotline, 41 616878333, global.trial_information@roche.com
    Scientific contact
    F. Hoffmann-La Roche AG, Roche Trial Information Hotline, 41 616878333, global.trial_information@roche.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
    30 Jun 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    • To evaluate the safety of multiple intravenous (IV) doses of MCMV5322A/MCMV3068A given to cytomegalovirus (CMV) seronegative recipients of a renal transplant from a CMV-seropositive donor. • To determine the clinical activity of multiple IV doses of MCMV5322A/MCMV3068A given to CMV-seronegative recipients of a renal transplant from a CMV-seropositive donor.
    Protection of trial subjects
    This study was conducted in full conformance with the International Conference on Harmonisation (ICH) E6 guideline for Good Clinical Practice and the principles of the Declaration of Helsinki or the laws and regulations of the country in which the research was conducted, whichever affords the greater protection to the individual.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Oct 2012
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Norway: 7
    Country: Number of subjects enrolled
    Spain: 13
    Country: Number of subjects enrolled
    Sweden: 12
    Country: Number of subjects enrolled
    United Kingdom: 6
    Country: Number of subjects enrolled
    Belgium: 9
    Country: Number of subjects enrolled
    Germany: 3
    Country: Number of subjects enrolled
    France: 12
    Country: Number of subjects enrolled
    United States: 58
    Worldwide total number of subjects
    120
    EEA total number of subjects
    62
    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)
    102
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 CMV-seronegative participants who received a renal allograf from a CMV-seropositive donor (D+R-) and met all inclusion/exclusion criteria were eligible for enrollment and randomization were screened and consented for enrollment.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MCMV5322A/MCMV3068A
    Arm description
    		 Participants received a total of four doses of MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.
    Arm type
    		 Experimental

    Investigational medicinal product name
    MCMV5322A/MCMV3068A
    Investigational medicinal product code
    RO6855849/RO6855848
    Other name
    RG7667
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MCMV5322A/MCMV3068A, 20 milligram per kilogram (mg/kg) [10 mg/kg each], IV infusion.

    Arm title
    		 Placebo
    Arm description
    		 Participants received a total of four doses of placebo matched with MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo matched with MCMV5322A/MCMV3068A, 20 mg/kg (10 mg/kg each), IV infusion.

    Number of subjects in period 1
    		MCMV5322A/MCMV3068A Placebo
    Started
    60
    60
    Completed
    48
    52
    Not completed
    12
    8
         Consent withdrawn by subject
    6
    2
         Physician decision
    -
    1
         Protocol violation
    1
    -
         Death
    2
    -
         Adverse event
    2
    3
         Unspecified
    1
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    MCMV5322A/MCMV3068A
    Reporting group description
    		 Participants received a total of four doses of MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a total of four doses of placebo matched with MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.

    Reporting group values
    		 MCMV5322A/MCMV3068A Placebo Total
    Number of subjects
    		 60 60 120
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.2 ( 14.3 ) 49.5 ( 12.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 18 18 36
        Male
    		 42 42 84

    End points

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    End points reporting groups
    Reporting group title
    MCMV5322A/MCMV3068A
    Reporting group description
    		 Participants received a total of four doses of MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a total of four doses of placebo matched with MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.

    Primary: Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) at Week 12

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    End point title
    		 Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) at Week 12
    End point description
    The CMV viral load was measured in copies/mL by quantitative polymerase chain reaction (PCR) in plasma during the entirety of the study, at least weekly during Weeks 0-12, and at least every 2 weeks for Weeks 13-24. Analysis was performed on modified intent to treat (mITT) population. mITT population included all the participants who received at least one dose of the study medication.
    End point type
    Primary
    End point timeframe
    Week 12
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    59
    57
    Units: percentage of participants
        number (not applicable)
    45.8
    61.4
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    MCMV5322A/MCMV3068A v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.101 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratum Adjusted Difference
    Point estimate
    15.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.8
         upper limit
    		 32.2
    Notes
    [1] - Comparison of MCMV5322A/MCMV3068A with placebo using Cochran‐Mantel‐Haenszel weights and stratified Newcombe Confidence Intervals.

    Secondary: Percentage of Participants With CMV Viral Load >=150 Copies/mL at Week 24

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    End point title
    		 Percentage of Participants With CMV Viral Load >=150 Copies/mL at Week 24
    End point description
    The CMV viral load was measured in copies/mL by quantitative PCR in plasma during the entirety of the study, at least weekly during Weeks 0-12, and at least every 2 weeks for Weeks 13-24. Analysis was performed on mITT population.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    59
    57
    Units: percentage of participants
        number (not applicable)
    50.8
    70.2
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    Placebo v MCMV5322A/MCMV3068A
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.035 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Stratum Adjusted Difference
    Point estimate
    19.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.4
         upper limit
    		 35.6
    Notes
    [2] - Comparison of MCMV5322A/MCMV3068A with placebo using Cochran‐Mantel‐Haenszel weights and stratified Newcombe Confidence Intervals

    Secondary: Time to Detectable CMV Viral Load >=150 Copies/mL

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    End point title
    		 Time to Detectable CMV Viral Load >=150 Copies/mL
    End point description
    Time to detectable CMV viral load is defined as a time from transplant to first CMV viral load of >=150 copies/mL as assessed by a central laboratory. Analysis was performed on mITT population. The value “99999” represents non evaluable (NE) data, as the upper limit of 95% confidence interval was not reached at the time of analysis.
    End point type
    Secondary
    End point timeframe
    Up to 24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    59
    57
    Units: days
        median (confidence interval 95%)
    139 (56 to 99999)
    46 (36 to 83)
    Statistical analysis title
    		 Statistical Analysis 1
    Comparison groups
    MCMV5322A/MCMV3068A v Placebo
    Number of subjects included in analysis
    116
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.009 [3]
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.532
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.329
         upper limit
    		 0.86
    Notes
    [3] - Median time to detectable CMV DNAemia was Kaplan‐Meier estimates and p‐value was computed using unstratified log rank test. Hazard ratios were estimated by Cox regression.

    Secondary: Viral Load at the First Detection of CMV Viremia (>=150 Copies/mL)

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    End point title
    		 Viral Load at the First Detection of CMV Viremia (>=150 Copies/mL)
    End point description
    The CMV viral load was measured in copies/mL by quantitative PCR in plasma during the entirety of the study.
    End point type
    Secondary
    End point timeframe
    Up to 24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: copies/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [4] - As the development of the drug was terminated, the planned analysis was not performed.
    [5] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Peak Viral Load on or Following First Detection of CMV viremia (>=150 Copies/mL)

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    End point title
    		 Peak Viral Load on or Following First Detection of CMV viremia (>=150 Copies/mL)
    End point description
    The CMV viral load was measured in copies/mL by quantitative PCR in plasma during the entirety of the study.
    End point type
    Secondary
    End point timeframe
    Up to 24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: copies/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [6] - As the development of the drug was terminated, the planned analysis was not performed.
    [7] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation

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    End point title
    		 Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation
    End point description
    Participants received pre-emptive antiviral therapy at the discretion of investigator, when viral load is felt to be clinically meaningful. A pre-emptive approach to CMV prevention involves initiation of anti-CMV therapy only in participants in whom early replication of CMV occurs rather than universal prophylaxis, where antiviral treatment is given to all transplant recipients at the time of transplantation.
    End point type
    Secondary
    End point timeframe
    12 and 24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: percentage of participants
        number (not applicable)
    Notes
    [8] - As the development of the drug was terminated, the planned analysis was not performed.
    [9] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Time to Initiation of First use of Preemptive Antiviral Therapy

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    End point title
    		 Time to Initiation of First use of Preemptive Antiviral Therapy
    End point description
    Time to initiation of pre-emptive antiviral therapy is the difference from the date of randomization to initiation of therapy.
    End point type
    Secondary
    End point timeframe
    24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: weeks
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [10] - As the development of the drug was terminated, the planned analysis was not performed.
    [11] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Duration of First use of Pre-emptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation

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    End point title
    		 Duration of First use of Pre-emptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation
    End point description
    Computation of duration of the use of pre-emptive antiviral therapy: if the participants received therapy till the end of the study, the duration was imputed as the median longest duration observed across all participants or the actual duration plus 1 week (delta) at the end of the study, whichever is the longer.
    End point type
    Secondary
    End point timeframe
    12, 24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: days
        median (confidence interval 95%)
    ( to )
    ( to )
    Notes
    [12] - As the development of the drug was terminated, the planned analysis was not performed.
    [13] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation

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    End point title
    		 Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation
    End point description
    Clinical evidence of CMV syndrome manifested by the presence of CMV in blood and at least one of the following: Fever of >=38 degree centigrade or 100.4 degree Fahrenheit, New or increased malaise, Leukopenia (white blood cells [WBC] of <3500/microliter [μL] or WBC decrease of >20%), Atypical lymphocytosis of >=5%, Thrombocytopenia (platelets count of <100000/μL or decrease of >20%). Clinical evidence of systemic CMV infection as manifested by the presence of CMV in the blood and at least one of the following: localized CMV infection in a biopsy or other appropriate specimen or relevant symptoms or signs of organ dysfunction that is unlikely to be due to other causes.
    End point type
    Secondary
    End point timeframe
    24 Weeks
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: percentage of participants
        number (not applicable)
    Notes
    [14] - As the development of the drug was terminated, the planned analysis was not performed.
    [15] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Secondary: Percentage of Participants With Change in CMV Serostatus

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    End point title
    		 Percentage of Participants With Change in CMV Serostatus
    End point description
    A single blood sample was collected at study completion/early termination to detect the presence of CMV antibodies (IgG) produced in response to CMV infection.
    End point type
    Secondary
    End point timeframe
    Week 24 or at early termination
    End point values
    		 MCMV5322A/MCMV3068A Placebo
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: percentage of participants
        number (not applicable)
    Notes
    [16] - As the development of the drug was terminated, the planned analysis was not performed.
    [17] - As the development of the drug was terminated, the planned analysis was not performed.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    24 Weeks
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    MCMV5322A/MCMV3068A
    Reporting group description
    		 Participants received a total of four doses of MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a pre-emptive approach for prevention of CMV disease.

    Reporting group title
    Placebo
    Reporting group description
    		 Participants received a total of four doses of placebo matched with MCMV5322A/MCMV3068A in CMV−seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease.

    Serious adverse events
    		 MCMV5322A/MCMV3068A Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 60 (50.00%)
    35 / 58 (60.34%)
         number of deaths (all causes)
    2
    2
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Adenocarcinoma
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Lymphocele
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bloody discharge
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Deep vein thrombosis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypertension
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (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
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery thrombosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Drug resistance
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General physical health deterioration
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperthermia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         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
    1 / 60 (1.67%)
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transplant rejection
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute respiratory failure
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea paroxysmal nocturnal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Interstitial lung disease
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mental status change
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    ECG signs of myocardial ischaemia
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal function test abnormal
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         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
    Abdominal wound dehiscence
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Graft loss
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arteriovenous fistula aneurysm
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Complications of transplanted kidney
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Perinephric collection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal haematoma
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Suture rupture
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary anastomotic leak
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (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
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Myocardial ischaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Anticholinergic syndrome
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ischaemic stroke
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         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
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Leukopenia
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Aplastic anaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neutropenia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Blindness
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diarrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retching
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (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 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Renal impairment
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hydronephrosis
         subjects affected / exposed
    2 / 60 (3.33%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ureteric stenosis
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urethral stenosis
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary retention
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Obstructive uropathy
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Proteinuria
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal cortical necrosis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal failure acute
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Musculoskeletal pain
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 5
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus viraemia
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    1 / 2
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis
         subjects affected / exposed
    2 / 60 (3.33%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus infection
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus syndrome
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 60 (1.67%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus enteritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cytomegalovirus gastroenteritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Escherichia pyelonephritis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes zoster
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osteomyelitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Parasitic encephalitis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumonia cytomegaloviral
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Post procedural cellulitis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Urosepsis
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Dehydration
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Fluid overload
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperglycaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    2 / 58 (3.45%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gout
         subjects affected / exposed
    1 / 60 (1.67%)
    0 / 58 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hyperkalaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypervolaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypocalcaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    1 / 58 (1.72%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 MCMV5322A/MCMV3068A Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    59 / 60 (98.33%)
    57 / 58 (98.28%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    13 / 60 (21.67%)
    8 / 58 (13.79%)
         occurrences all number
    13
    9
    Hypotension
         subjects affected / exposed
    5 / 60 (8.33%)
    6 / 58 (10.34%)
         occurrences all number
    9
    6
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    11 / 60 (18.33%)
    8 / 58 (13.79%)
         occurrences all number
    11
    8
    Pyrexia
         subjects affected / exposed
    5 / 60 (8.33%)
    11 / 58 (18.97%)
         occurrences all number
    7
    13
    Oedema peripheral
         subjects affected / exposed
    6 / 60 (10.00%)
    6 / 58 (10.34%)
         occurrences all number
    9
    6
    Peripheral swelling
         subjects affected / exposed
    4 / 60 (6.67%)
    5 / 58 (8.62%)
         occurrences all number
    4
    5
    Asthenia
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
         occurrences all number
    4
    3
    Oedema
         subjects affected / exposed
    3 / 60 (5.00%)
    4 / 58 (6.90%)
         occurrences all number
    3
    4
    Chest pain
         subjects affected / exposed
    0 / 60 (0.00%)
    4 / 58 (6.90%)
         occurrences all number
    0
    4
    Pain
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 58 (5.17%)
         occurrences all number
    1
    3
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 58 (6.90%)
         occurrences all number
    1
    6
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    4 / 60 (6.67%)
    6 / 58 (10.34%)
         occurrences all number
    4
    6
    Cough
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 58 (8.62%)
         occurrences all number
    3
    6
    Oropharyngeal pain
         subjects affected / exposed
    3 / 60 (5.00%)
    4 / 58 (6.90%)
         occurrences all number
    3
    4
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    4 / 60 (6.67%)
    8 / 58 (13.79%)
         occurrences all number
    7
    8
    Anxiety
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
         occurrences all number
    4
    3
    Investigations
    Cytomeglaovirus test positive
         subjects affected / exposed
    7 / 60 (11.67%)
    6 / 58 (10.34%)
         occurrences all number
    9
    13
    Blood creatinine increased
         subjects affected / exposed
    4 / 60 (6.67%)
    7 / 58 (12.07%)
         occurrences all number
    4
    10
    Weight increased
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Blood uric acid increased
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    5 / 60 (8.33%)
    2 / 58 (3.45%)
         occurrences all number
    5
    2
    Complications of transplant surgery
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
         occurrences all number
    1
    5
    Arteriovenous fistula thrombosis
         subjects affected / exposed
    1 / 60 (1.67%)
    4 / 58 (6.90%)
         occurrences all number
    1
    4
    Complications of transplanted kidney
         subjects affected / exposed
    4 / 60 (6.67%)
    1 / 58 (1.72%)
         occurrences all number
    4
    1
    Incision site pain
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Graft complication
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    Ligament Sprain
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    Cardiac disorders
    Tachycardia
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    Nervous system disorders
    Tremor
         subjects affected / exposed
    11 / 60 (18.33%)
    7 / 58 (12.07%)
         occurrences all number
    13
    7
    Headache
         subjects affected / exposed
    7 / 60 (11.67%)
    8 / 58 (13.79%)
         occurrences all number
    7
    8
    Dizziness
         subjects affected / exposed
    9 / 60 (15.00%)
    3 / 58 (5.17%)
         occurrences all number
    10
    3
    Hypoaesthesia
         subjects affected / exposed
    7 / 60 (11.67%)
    1 / 58 (1.72%)
         occurrences all number
    7
    1
    Paraesthesia
         subjects affected / exposed
    2 / 60 (3.33%)
    5 / 58 (8.62%)
         occurrences all number
    2
    5
    Lethargy
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    16 / 60 (26.67%)
    20 / 58 (34.48%)
         occurrences all number
    18
    20
    Leukopenia
         subjects affected / exposed
    4 / 60 (6.67%)
    13 / 58 (22.41%)
         occurrences all number
    4
    14
    Neutropenia
         subjects affected / exposed
    2 / 60 (3.33%)
    8 / 58 (13.79%)
         occurrences all number
    2
    8
    Thrombocytopenia
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
         occurrences all number
    1
    5
    Leukocytosis
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Lymphopenia
         subjects affected / exposed
    1 / 60 (1.67%)
    3 / 58 (5.17%)
         occurrences all number
    1
    3
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    22 / 60 (36.67%)
    19 / 58 (32.76%)
         occurrences all number
    26
    24
    Nausea
         subjects affected / exposed
    9 / 60 (15.00%)
    14 / 58 (24.14%)
         occurrences all number
    11
    15
    Constipation
         subjects affected / exposed
    12 / 60 (20.00%)
    10 / 58 (17.24%)
         occurrences all number
    13
    11
    Vomiting
         subjects affected / exposed
    5 / 60 (8.33%)
    10 / 58 (17.24%)
         occurrences all number
    5
    11
    Dyspepsia
         subjects affected / exposed
    7 / 60 (11.67%)
    5 / 58 (8.62%)
         occurrences all number
    8
    7
    Abdominal pain
         subjects affected / exposed
    4 / 60 (6.67%)
    7 / 58 (12.07%)
         occurrences all number
    5
    7
    Abdominal distension
         subjects affected / exposed
    2 / 60 (3.33%)
    3 / 58 (5.17%)
         occurrences all number
    2
    3
    Flatulence
         subjects affected / exposed
    3 / 60 (5.00%)
    2 / 58 (3.45%)
         occurrences all number
    3
    2
    Abdominal pain upper
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    4 / 60 (6.67%)
    2 / 58 (3.45%)
         occurrences all number
    4
    2
    Ecchymosis
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    Renal and urinary disorders
    Proteinuria
         subjects affected / exposed
    4 / 60 (6.67%)
    3 / 58 (5.17%)
         occurrences all number
    4
    3
    Haematuria
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
         occurrences all number
    1
    5
    Renal impairment
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
         occurrences all number
    4
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 60 (5.00%)
    8 / 58 (13.79%)
         occurrences all number
    3
    10
    Arthralgia
         subjects affected / exposed
    5 / 60 (8.33%)
    5 / 58 (8.62%)
         occurrences all number
    5
    6
    Muscle spasms
         subjects affected / exposed
    3 / 60 (5.00%)
    5 / 58 (8.62%)
         occurrences all number
    3
    5
    Pain in extremity
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 58 (6.90%)
         occurrences all number
    4
    5
    Infections and infestations
    Cytomegalovirus viraemia
         subjects affected / exposed
    13 / 60 (21.67%)
    20 / 58 (34.48%)
         occurrences all number
    15
    33
    Urinary tract infection
         subjects affected / exposed
    14 / 60 (23.33%)
    19 / 58 (32.76%)
         occurrences all number
    17
    27
    Cytomegalovirus infection
         subjects affected / exposed
    13 / 60 (21.67%)
    16 / 58 (27.59%)
         occurrences all number
    17
    18
    Viraemia
         subjects affected / exposed
    5 / 60 (8.33%)
    6 / 58 (10.34%)
         occurrences all number
    5
    7
    Nasopharyngitis
         subjects affected / exposed
    2 / 60 (3.33%)
    6 / 58 (10.34%)
         occurrences all number
    2
    8
    Cytomegalovirus syndrome
         subjects affected / exposed
    1 / 60 (1.67%)
    5 / 58 (8.62%)
         occurrences all number
    1
    6
    Upper respiratory tract infection
         subjects affected / exposed
    5 / 60 (8.33%)
    1 / 58 (1.72%)
         occurrences all number
    5
    2
    BK virus infection
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0
    Enterococcal infection
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Metabolism and nutrition disorders
    Hyperkalaemia
         subjects affected / exposed
    7 / 60 (11.67%)
    12 / 58 (20.69%)
         occurrences all number
    8
    15
    Hypomagnesaemia
         subjects affected / exposed
    8 / 60 (13.33%)
    11 / 58 (18.97%)
         occurrences all number
    8
    12
    Hypophosphataemia
         subjects affected / exposed
    10 / 60 (16.67%)
    8 / 58 (13.79%)
         occurrences all number
    10
    9
    Metabolic acidosis
         subjects affected / exposed
    7 / 60 (11.67%)
    8 / 58 (13.79%)
         occurrences all number
    9
    9
    Decreased Appetite
         subjects affected / exposed
    4 / 60 (6.67%)
    8 / 58 (13.79%)
         occurrences all number
    4
    9
    Hypokalaemia
         subjects affected / exposed
    5 / 60 (8.33%)
    6 / 58 (10.34%)
         occurrences all number
    5
    7
    Hyperglycaemia
         subjects affected / exposed
    3 / 60 (5.00%)
    6 / 58 (10.34%)
         occurrences all number
    3
    7
    Hypercalcaemia
         subjects affected / exposed
    4 / 60 (6.67%)
    4 / 58 (6.90%)
         occurrences all number
    5
    4
    Hypocalcaemia
         subjects affected / exposed
    3 / 60 (5.00%)
    4 / 58 (6.90%)
         occurrences all number
    3
    4
    Diabetes mellitus
         subjects affected / exposed
    3 / 60 (5.00%)
    3 / 58 (5.17%)
         occurrences all number
    3
    5
    Fluid overload
         subjects affected / exposed
    4 / 60 (6.67%)
    0 / 58 (0.00%)
         occurrences all number
    4
    0
    Hyponatraemia
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
         occurrences all number
    4
    1
    Vitamin D deficiency
         subjects affected / exposed
    3 / 60 (5.00%)
    1 / 58 (1.72%)
         occurrences all number
    3
    1
    Hypercholesterolaemia
         subjects affected / exposed
    0 / 60 (0.00%)
    3 / 58 (5.17%)
         occurrences all number
    0
    3
    Iron deficiency
         subjects affected / exposed
    3 / 60 (5.00%)
    0 / 58 (0.00%)
         occurrences all number
    3
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Oct 2012
    Protocol was amended to clarify the inclusion criteria relating to sexual abstinence in the context of contraception and to clarify the process for emergency unblinding of study treatment.
    30 Oct 2012
    Protocol was amended to clarify the algorithm for resistance testing. The protocol was also revised to enhance the clarity of the Study Flowchart by including a footnote that references and to clarify that protocol-related decisions (e.g., additional visits between Weeks 13 and 24) are to be based on central, not local, laboratory viral load results.
    15 Jul 2013
    The study population was changed to 120 participants (60 active and 60 placebo) and the window for study drug administration was changed to 24 hours before transplantation.

    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.
    As the development of the drug was terminated, the planned analysis of some secondary endpoints was not performed.
    For support, Contact us.
    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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