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
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EudraCT number |
2015-002812-33 |
Trial protocol |
GB ES |
Global end of trial date |
06 Mar 2018
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Results information
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Results version number |
v2 |
This version publication date |
03 Aug 2018
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First version publication date |
15 Apr 2018
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Other versions |
v1 , v3 , v4 |
Version creation reason |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
204824
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
GlaxoSmithKline
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Sponsor organisation address |
980 Great West Road, Brentford, Middlesex, United Kingdom,
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Public contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Scientific contact |
GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Interim
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Date of interim/final analysis |
23 Jun 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Mar 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Mar 2018
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Was the trial ended prematurely? |
Yes
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General information about the trial
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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
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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.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Aug 2016
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
United Kingdom: 6
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Worldwide total number of subjects |
7
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EEA total number of subjects |
7
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
5
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From 65 to 84 years |
2
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85 years and over |
0
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Recruitment
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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
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Screening details |
A total of 10 participants were screened for the study, and 7 of them received study treatment. The study enrolled participants in 4 centers across 2 countries (Spain and United Kingdom). | ||||||||||
Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Arms
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Arm title
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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
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Infusion
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Routes of administration |
Intravenous use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
GSK1070806 3 mg/kg IV
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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. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
GSK1070806 3 mg/kg IV
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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. |
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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 hyperkalemia 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. 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. Statistical analysis was carried out using Bayesian methodology. The proportion of participants with DGF was 0.57, highest Posterior Density (HPD) 95% Credible interval (CI) (0.25,0.90). The posterior probability for the proportion of participants with DGF <30% was 0.07 (HPD 95% CI [0.00,1.00]). The posterior probability for the proportion of participants with DGF <50% was 0.34 (HPD 95% CI [0.00,1.00]).
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End point type |
Primary
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End point timeframe |
Up to Day 7
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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: As this is a single arm study, statistical analyses have been specified in Primary End Point Description. |
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Notes [2] - AP Population |
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No statistical analyses for this end point |
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End point title |
Serum creatinine at Baseline and Change from Baseline over time post transplant | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Blood samples were 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. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates data is not available as standard deviation could not be calculated due to n=1. The AP Population is defined as participants having Baseline and at least one post-Baseline assessment.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 months
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Notes [3] - AP Population |
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No statistical analyses for this end point |
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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 December 2018.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 months
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Notes [4] - All Subjects Population |
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No statistical analyses for this end point |
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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 evaluated to access graft function in DCD renal transplant recipients treated with GSK1070806.
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End point type |
Secondary
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End point timeframe |
Up to Day 7
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Notes [5] - All Subjects Population |
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No statistical analyses for this end point |
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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 evaluated to assess the effect of GSK1070806 on acute rejection risk, and rejection/ Pharmacodynamics (PD) biomarkers. Only those participants with data available at the specified time points were analyzed.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [6] - AP Population |
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No statistical analyses for this end point |
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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. The AP Population is defined as participants having Baseline and at least one post-Baseline assessment. Data will be posted by December 2018.
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End point type |
Secondary
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End point timeframe |
Baseline and up to 12 months
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Notes [7] - AP Population |
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No statistical analyses for this end point |
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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. The AP Population is defined as participants having Baseline and at least one post-Baseline assessment.
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End point type |
Secondary
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End point timeframe |
Up to 30 days
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Notes [8] - AP Population |
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No statistical analyses for this end point |
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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 evaluated to assess the effect of GSK1070806 on dialysis dependency and graft survival.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [9] - All Subjects Population |
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No statistical analyses for this end point |
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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.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [10] - AP Population |
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No statistical analyses for this end point |
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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 were to be presented. Data will be posted by December 2018.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [11] - All Subjects Population |
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No statistical analyses for this end point |
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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 were to be presented. Data will be posted by December 2018.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [12] - All Subjects Population |
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No statistical analyses for this end point |
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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 were to be presented. Data will be posted by December 2018.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [13] - All Subjects Population |
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No statistical analyses for this end point |
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End point title |
Number of participants having infections | ||||||
End point description |
Number of participants having infections were summarized.
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End point type |
Secondary
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End point timeframe |
Up to 12 months
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Notes [14] - All Subjects Population |
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No statistical analyses for this end point |
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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 December 2018.
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End point type |
Secondary
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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
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Notes [15] - PK Population |
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No statistical analyses for this end point |
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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 December 2018.
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End point type |
Secondary
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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
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Notes [16] - PK Population |
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No statistical analyses for this end point |
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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 December 2018.
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End point type |
Secondary
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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
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Notes [17] - PK Population |
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No statistical analyses for this end point |
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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 December 2018.
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End point type |
Secondary
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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
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Notes [18] - All Subjects Population |
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No statistical analyses for this end point |
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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 was not collected as the immunogenicity samples were not analyzed for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.
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End point type |
Secondary
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End point timeframe |
Pre-dose, Day 30, Day 90, 6 and 12 months
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Notes [19] - All Subjects Population |
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No statistical analyses for this end point |
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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 was not collected as the immunogenicity samples were not analyzed for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.
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End point type |
Secondary
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End point timeframe |
Pre-dose, Day 30, Day 90, 6 and 12 months
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Notes [20] - All Subjects Population |
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No statistical analyses for this end point |
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Adverse events information
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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.
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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.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
2.0
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Reporting groups
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Reporting group title |
GSK1070806 3 mg/kg IV
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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. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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03 Feb 2016 |
Amendment 01: Updates to clarify select safety criteria; completion of abbreviations table. |
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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. |
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22 Mar 2017 |
Amendment 03: Dose escalation: clarifications based on data from patients receiving 3 mg/kg dose to escalate to higher dose. |
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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. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |