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    Clinical Trial Results:
    A Phase 2 Pilot, Multicenter, Single Arm Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of GSK1070806 plus Standard of Care for the Prevention of Delayed Graft Function in Adult Subjects After Renal Transplantation

    Summary
    EudraCT number
    		 2015-002812-33
    Trial protocol
    		 GB   ES  
    Global end of trial date
    06 Mar 2018

    Results information
    Results version number
    		 v1
    This version publication date
    15 Apr 2018
    First version publication date
    15 Apr 2018
    Other versions
    		 v2 , v3 , v4

    Trial information

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    Trial identification
    Sponsor protocol code
    204824
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlaxoSmithKline
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    23 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Mar 2018
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the frequency of delayed graft function (DGF) in donation after circulatory death (DCD) renal transplant recipients treated with GSK1070806
    Protection of trial subjects
    This study uses standard of care (SoC) aligning study tasks with SoC tasks and visit schedule to mitigate participant study-burden. Additionally, participants are required to use additional anti-infective protocols due to the potential of GSK1070806 to increase immunosuppression.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Aug 2016
    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
    Spain: 1
    Country: Number of subjects enrolled
    United Kingdom: 6
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    5
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This was a single arm study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of GSK1070806 plus standard of care (SOC) for the prevention of delayed graft function in adult participants after renal transplantation. The results presented are based on the Interim Analysis.

    Pre-assignment
    Screening details
    		 A total of 7 participants were screened for the study, and all of them received study treatment. The study enrolled participants in 4 centers across 2 countries (Spain and United Kingdom).

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

    Arms
    Arm title
    		 GSK1070806 3 mg/kg IV
    Arm description
    		 Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
    Arm type
    		 Experimental

    Investigational medicinal product name
    GSK1070806
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion.

    Number of subjects in period 1
    		GSK1070806 3 mg/kg IV
    Started
    7
    Completed
    6
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK1070806 3 mg/kg IV
    Reporting group description
    		 Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.

    Reporting group values
    		 GSK1070806 3 mg/kg IV Total
    Number of subjects
    		 7
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 58.7 ± 13.46 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 7 7
    Race/Ethnicity, Customized
    Units: Subjects
        White-White/Caucasian/European Heritage
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    GSK1070806 3 mg/kg IV
    Reporting group description
    		 Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.

    Primary: Number of participants requiring dialysis during the first 7 days post transplant

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    End point title
    		 Number of participants requiring dialysis during the first 7 days post transplant [1]
    End point description
    The requirement of dialysis (except as needed for hyperkalaemia during the first 24 hours [hrs]) were used to assess the frequency of delayed graft function (DGF) in donation after circulatory death (DCD) renal transplant recipients treated with GSK1070806. For DGF related endpoints, the ‘Analysis Population’ (AP) is defined as participants in the ‘All Subjects’ Population who have been declared to have DGF or have reached 7 days. For other endpoints, the AP is defined as participants having Baseline and at least one post-Baseline assessment.
    End point type
    Primary
    End point timeframe
    Up to Day 7
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are no statistical data to report.
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    7 [2]
    Units: Participants
        Participants
    5
    Notes
    [2] - AP Population
    No statistical analyses for this end point

    Secondary: Serum creatinine at Baseline and over time post transplant

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    End point title
    		 Serum creatinine at Baseline and over time post transplant
    End point description
    Blood samples were to be collected to measure serum creatinine at the indicated timepoints to assess graft function in DCD renal transplant recipients treated with GSK1070806. Baseline value was the latest pre-dose assessment value. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [3]
    Units: Micromoles per liter
        arithmetic mean (standard deviation)
    ±
    Notes
    [3] - AP Population
    No statistical analyses for this end point

    Secondary: Urine volume at Baseline and over time post transplant

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    End point title
    		 Urine volume at Baseline and over time post transplant
    End point description
    Urine volume at Baseline and over time post transplant was to be measured to assess graft function in DCD renal transplant recipients treated with GSK1070806. Baseline value was the latest pre-dose assessment value. All Subjects Population comprised of participants who received the dose of study medication. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [4]
    Units: Milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [4] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants in the first 7 days with: primary non function, functional DGF, intermediate graft function, immediate graft function

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    End point title
    		 Number of participants in the first 7 days with: primary non function, functional DGF, intermediate graft function, immediate graft function
    End point description
    Number of participants in the first 7 days with primary non function, functional DGF, intermediate graft function and immediate graft function were to be evaluated to access graft function in DCD renal transplant recipients treated with GSK1070806. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to Day 7
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [5]
    Units: Participants
    Notes
    [5] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with episodes of biopsy-proven acute rejection

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    End point title
    		 Number of participants with episodes of biopsy-proven acute rejection
    End point description
    Number of participants with episodes of biopsy-proven acute rejection were to be evaluated to assess the effect of GSK1070806 on acute rejection risk, and rejection/Pharmacodynamic (PD) biomarkers. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [6]
    Units: Participants
    Notes
    [6] - AP Population
    No statistical analyses for this end point

    Secondary: Serum Interferon gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma interferon (Mig) levels at Baseline and over time post transplant

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    End point title
    		 Serum Interferon gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma interferon (Mig) levels at Baseline and over time post transplant
    End point description
    The interferon-gamma -inducible chemokine IP10 and the interferon-gamma -inducible chemokine Mig have been identified as an early predictive marker of antibody-mediated kidney graft rejection. Baseline value was the latest pre-dose assessment value. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [7]
    Units: Participants
    Notes
    [7] - AP Population
    No statistical analyses for this end point

    Secondary: Number of participants with dialysis events in the first 30 days post-transplant

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    End point title
    		 Number of participants with dialysis events in the first 30 days post-transplant
    End point description
    Number of participants with dialysis events in the first 30 days post transplant was evaluated to assess the effect of GSK1070806 on dialysis dependency and graft survival.
    End point type
    Secondary
    End point timeframe
    Up to 30 days
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    7 [8]
    Units: Participants
        Participants
    5
    Notes
    [8] - AP Population
    No statistical analyses for this end point

    Secondary: Number of participants who are dialysis independent at visits up to 12 months post-transplant

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    End point title
    		 Number of participants who are dialysis independent at visits up to 12 months post-transplant
    End point description
    Number of participants who are dialysis independent at visits up to 12 months post transplant was to be evaluated to assess the effect of GSK1070806 on dialysis dependency and graft survival. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [9]
    Units: Participants
    Notes
    [9] - AP Population
    No statistical analyses for this end point

    Secondary: Number of participants with adverse event (AE) and serious adverse event (SAE)

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    End point title
    		 Number of participants with adverse event (AE) and serious adverse event (SAE)
    End point description
    AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment were categorized as SAE. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    7 [10]
    Units: Participants
        Any AE
    7
        Any SAE
    6
    Notes
    [10] - AP Population
    No statistical analyses for this end point

    Secondary: Number of participants having any emergent hematology results of Potential Clinical Importance

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    End point title
    		 Number of participants having any emergent hematology results of Potential Clinical Importance
    End point description
    Hematology parameters included platelet counts, red blood cells (RBC) count, hemoglobin, hematocrit, mean corpuscular volume (MCV), mean corpuscular haemoglobin (MCH), white blood cells (WBC) count with differential neutrophils, lymphocytes, monocytes, eosinophils, and basophils. Number of participants with potential clinical importance (high or low) results in any of these parameters are presented.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    6 [11]
    Units: Participants
        High
    2
        Low
    6
    Notes
    [11] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants having any emergent clinical chemistry results of Potential Clinical Importance

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    End point title
    		 Number of participants having any emergent clinical chemistry results of Potential Clinical Importance
    End point description
    Clinical chemistry parameters included analysis of urea, creatinine, glucose, potassium, sodium, calcium, Gamma-Glutamyl Transferase (GGT), alanine aminotransferase (ALT), alkaline phosphatise, bilirubin, total protein and albumin levels. Number of participants with potential clinical importance (high or low) results in any of these parameters are presented.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    6 [12]
    Units: Participants
        High
    4
        Low
    6
    Notes
    [12] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants having any abnormality of Potential Clinical Importance of vital signs results

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    End point title
    		 Number of participants having any abnormality of Potential Clinical Importance of vital signs results
    End point description
    Vital signs parameters included analysis of systolic and diastolic blood pressure, heart rate and body temperature. Number of participants with any abnormality of potential clinical importance (high or low) in any of these vitals signs are presented.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    7 [13]
    Units: Participants
        High
    4
        Low
    3
    Notes
    [13] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants having infections

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    End point title
    		 Number of participants having infections
    End point description
    Number of participants having infections was to be summarized. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Up to 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [14]
    Units: Participants
    Notes
    [14] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Serum concentrations of GSK1070806

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    End point title
    		 Serum concentrations of GSK1070806
    End point description
    Serial blood samples were to be collected to evaluate PK of GSK1070806 at pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months. PK Population included participants in the ‘All Subjects’ Population for whom a serum PK sample is obtained and analyzed for GSK1070806. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [15]
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [15] - PK Population
    No statistical analyses for this end point

    Secondary: Maximum plasma concentration (Cmax) of GSK1070806

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    End point title
    		 Maximum plasma concentration (Cmax) of GSK1070806
    End point description
    Serial blood samples were collected to evaluate PK of GSK1070806 at pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [16]
    Units: Micrograms per milliliter
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [16] - PK Population
    No statistical analyses for this end point

    Secondary: Area under the plasma concentration time curve (AUC) from time 0 to 168 hours (AUC[0-168]) and AUC from time 0 to 672 hours (AUC[0-672]) of GSK1070806

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    End point title
    		 Area under the plasma concentration time curve (AUC) from time 0 to 168 hours (AUC[0-168]) and AUC from time 0 to 672 hours (AUC[0-672]) of GSK1070806
    End point description
    Blood samples were to be collected to evaluate PK of GSK1070806 at pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.75 hours, 4-8 hours, 24 hours, 168 hours (or at discharge) after kidney reperfusion, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [17]
    Units: Hour*milligrams per milliliter
        geometric mean (geometric coefficient of variation)
    ±
    Notes
    [17] - PK Population
    No statistical analyses for this end point

    Secondary: Serum levels of free, total, and GSK1070806 bound Interleukin 18 (IL-18) levels at Baseline and over time post-transplant

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    End point title
    		 Serum levels of free, total, and GSK1070806 bound Interleukin 18 (IL-18) levels at Baseline and over time post-transplant
    End point description
    IL-18 is itself rapidly secreted from intracellular stores following inflammasome mediated-activation. The appearance of IL-18 marks the initiation of the inflammatory response leading to further injury. Baseline value was the latest pre-dose assessment value. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.75 hours, 4-8 hours, Day 1, Day 2, at discharge, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [18]
    Units: Picograms per milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [18] - All Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with positive result in anti-GSK1070806 antibodies (ADAs)

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    End point title
    		 Number of participants with positive result in anti-GSK1070806 antibodies (ADAs)
    End point description
    Serum samples were to be collected to test for the presence of antibodies against GSK1070806 at indicated time points. The presence of anti-GSK1070806 binding antibodies were to be assessed using a validated electrochemiluminescent (ECL) immunoassay. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [19]
    Units: Participants
    Notes
    [19] - All Subjects Population
    No statistical analyses for this end point

    Secondary: ADA titer before and after GSK1070806 administration

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    End point title
    		 ADA titer before and after GSK1070806 administration
    End point description
    Serum samples were to be collected to test for the presence of antibodies against GSK1070806 at indicated time points. The presence of ADA titre was to be assessed using a validated ECL immunoassay. Data will be posted by July 2018.
    End point type
    Secondary
    End point timeframe
    Pre-dose, Day 30, Day 90, 6 and 12 months
    End point values
    		 GSK1070806 3 mg/kg IV
    Number of subjects analysed
    0 [20]
    Units: Nanograms per milliliter
        arithmetic mean (standard deviation)
    ±
    Notes
    [20] - All Subjects Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
    Adverse event reporting additional description
    SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    GSK1070806 3 mg/kg IV
    Reporting group description
    		 Participants received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Participants also received a combination immunosuppression comprised of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.

    Serious adverse events
    		 GSK1070806 3 mg/kg IV
    Total subjects affected by serious adverse events
         subjects affected / exposed
    6 / 7 (85.71%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Injury, poisoning and procedural complications
    Transplant dysfunction
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Ventricular fibrillation
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    Surgical and medical procedures
    Ureteral stent removal
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Hernia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Prostatomegaly
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Respiratory arrest
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    Ureteric obstruction
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Urinary tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 GSK1070806 3 mg/kg IV
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 7 (100.00%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Surgical and medical procedures
    Renal transplant biopsy
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    General disorders and administration site conditions
    Catheter site haemorrhage
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Immune system disorders
    Kidney transplant rejection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Wheezing
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Investigations
    Blood creatine increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Blood potassium decreased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Blood sodium decreased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Body temperature decreased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Candida test positive
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Haemoglobin increased
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Wound dehiscence
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Wound evisceration
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Nervous system disorders
    Tremor
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    4 / 7 (57.14%)
         occurrences all number
    4
    Leukopenia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Neutropenia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Thrombocytopenia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3
    Abdominal pain
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Inguinal hernia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Frequent bowel movements
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Lip swelling
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Nail discolouration
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Decubitus ulcer
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Urticaria
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    4
    Renal disorder
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Ureteric stenosis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Urine - vancomycin resistent enterococcus positive
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Infections and infestations
    Urinary tract infection
         subjects affected / exposed
    2 / 7 (28.57%)
         occurrences all number
    4
    Escherichia urinary tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Postoperative wound infection
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Pyelonephritis acute
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Acidosis
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Diabetes mellitus
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Fluid overload
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hypoglycaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    2
    Hypophosphataemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    03 Feb 2016
    Amendment 01: Updates to clarify select safety criteria; completion of abbreviations table.
    09 Aug 2016
    Amendment 02: Eligibility Criteria: Allowance of second kidney transplant recipients for enrollment, removal of upper age limits, addition of definition for ‘surgical damage’ related to transplant organ retrieval; and clarifications to interim analysis and DCD categorization type.
    22 Mar 2017
    Amendment 03: Dose escalation: clarifications based on data from patients receiving 3 mg/kg dose to escalate to higher dose.
    04 May 2017
    Amendment 04: Eligibility Criteria: Additional exclusion criteria have been added to reduce the chance of enrolling participants with high cardiac risk profiles. Dose escalation: Based on emergent efficacy and pharmacokinetic-pharmacodynamics (PKPD) data, the number of participants required to be treated prior to a decision to escalate dose has been reduced, and stopping criteria following dose escalation have been amended.

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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