Trial Outcomes & Findings for Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation (NCT NCT02723786)
NCT ID: NCT02723786
Last Updated: 2019-06-26
Results Overview
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. 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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to Day 7
Results posted on
2019-06-26
Participant Flow
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.
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).
Participant milestones
| Measure |
GSK1070806 3 mg/kg IV
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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|---|---|
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Overall Study
STARTED
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7
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Overall Study
COMPLETED
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6
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
GSK1070806 3 mg/kg IV
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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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation
Baseline characteristics by cohort
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Age, Continuous
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58.7 Years
STANDARD_DEVIATION 13.46 • n=5 Participants
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Sex: Female, Male
Female
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0 Participants
n=5 Participants
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Sex: Female, Male
Male
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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7 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to Day 7Population: AP Population
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. 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.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Number of Participants Requiring Dialysis During the First 7 Days Post Transplant
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4 Participants
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SECONDARY outcome
Timeframe: Baseline and up to 12 monthsPopulation: AP Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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. Change from Baseline was post Baseline value minus Baseline value. NA 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.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 0, n=7
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-39.3 Micromoles per liter
Standard Deviation 160.09
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 1, n=7
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-44.7 Micromoles per liter
Standard Deviation 214.06
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 3, n=7
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-36.7 Micromoles per liter
Standard Deviation 378.28
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 4, n=7
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-104.6 Micromoles per liter
Standard Deviation 378.79
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 5, n=6
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-57.2 Micromoles per liter
Standard Deviation 334.19
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 6, n=6
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-75.7 Micromoles per liter
Standard Deviation 308.22
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 7, n=6
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-43.5 Micromoles per liter
Standard Deviation 321.91
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 8, n=5
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-150.8 Micromoles per liter
Standard Deviation 293.48
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 9, n=3
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-24.0 Micromoles per liter
Standard Deviation 297.82
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 10, n=3
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-53.0 Micromoles per liter
Standard Deviation 395.94
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Screening, n=7
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679.0 Micromoles per liter
Standard Deviation 175.14
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 2, n=7
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-99.0 Micromoles per liter
Standard Deviation 304.29
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 11, n=3
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-97.0 Micromoles per liter
Standard Deviation 462.46
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 12, n=2
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110.0 Micromoles per liter
Standard Deviation 257.39
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 13, n=2
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38.0 Micromoles per liter
Standard Deviation 209.30
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 14, n=2
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4.0 Micromoles per liter
Standard Deviation 190.92
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 15, n=2
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-51.0 Micromoles per liter
Standard Deviation 172.53
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 16, n=2
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-61.5 Micromoles per liter
Standard Deviation 173.24
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 17, n=2
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-107.5 Micromoles per liter
Standard Deviation 143.54
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 18, n=2
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-145.0 Micromoles per liter
Standard Deviation 123.04
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 19, n=2
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-173.5 Micromoles per liter
Standard Deviation 95.46
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 20, n=2
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-183.5 Micromoles per liter
Standard Deviation 81.32
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 21, n=1
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-117.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 22, n=1
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-91.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 23, n=1
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-95.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 24, n=1
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-115.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 25, n=1
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-152.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 26, n=1
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-155.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 27, n=1
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-175.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 28, n=1
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-191.0 Micromoles per liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 30, n=7
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-478.3 Micromoles per liter
Standard Deviation 225.47
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
Day 90, n=7
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-489.9 Micromoles per liter
Standard Deviation 214.06
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
6 months, n=7
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-467.4 Micromoles per liter
Standard Deviation 232.49
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Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
12 months, n=6
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-490.5 Micromoles per liter
Standard Deviation 224.32
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SECONDARY outcome
Timeframe: Baseline (Pre-operative) and up to Day 28Population: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Urine volume at Baseline and over time post transplant was measured to assess graft function in DCD renal transplant recipients treated with GSK1070806. Baseline value was the latest pre-dose assessment value. Change from Baseline was post Baseline value minus Baseline value. All Subjects Population comprised of participants who received the dose of study medication.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Baseline (Pre-operative), n=5
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0.6700 Liter
Standard Deviation 0.60581
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 7, n=4
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1.2985 Liter
Standard Deviation 1.37212
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 28, n=1
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1.4600 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 0, n=4
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-0.5150 Liter
Standard Deviation 0.59533
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 1, n=5
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0.5862 Liter
Standard Deviation 1.56917
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 2, n=5
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1.2820 Liter
Standard Deviation 2.62989
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 3, n=5
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0.8840 Liter
Standard Deviation 1.04040
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 4, n=5
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1.1480 Liter
Standard Deviation 1.00442
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 5, n=4
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0.8270 Liter
Standard Deviation 1.02297
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 6, n=4
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1.1168 Liter
Standard Deviation 1.30252
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 8, n=3
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1.2090 Liter
Standard Deviation 1.20354
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 9, n=2
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1.2135 Liter
Standard Deviation 1.46866
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 10, n=2
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0.8585 Liter
Standard Deviation 0.62720
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 11, n=2
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0.4985 Liter
Standard Deviation 0.22840
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 12, n=1
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1.4000 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 13, n=1
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1.6900 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 14, n=1
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1.1800 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 15, n=1
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1.5500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 16, n=1
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1.8500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 17, n=1
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1.5000 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 18, n=1
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1.9000 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 19, n=1
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1.6000 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 20, n=1
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1.2500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 21, n=1
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0.7500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 22, n=1
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1.0500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 23, n=1
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1.1500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 24, n=1
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1.4500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 25, n=1
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2.0500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 26, n=1
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2.0000 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
Day 27, n=1
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1.5500 Liter
Standard Deviation NA
Standard deviation could not be calculated due to n=1.
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SECONDARY outcome
Timeframe: Up to Day 7Population: All Subjects Population
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. The AP Population is defined as participants in the 'All Subjects' Population who have been declared to have DGF or have reached 7 days.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
Primary Non Function
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1 Participants
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
3 day Functional DGF
|
3 Participants
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
7 day Immediate Graft Function
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0 Participants
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
7 day Functional DGF
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5 Participants
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
3 day Intermediate Graft Function
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0 Participants
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Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
7 day Intermediate Graft Function
|
1 Participants
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|
Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
3 day Immediate Graft Function
|
1 Participants
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SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population. Only those participants with data available at the specified time points were analyzed.
Number of participants with episodes of biopsy-proven acute rejection were evaluated to assess the effect of GSK1070806 on acute rejection risk, and rejection/Pharmacodynamic (PD) biomarkers.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=2 Participants
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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|---|---|
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Number of Participants With Episodes of Biopsy-proven Acute Rejection
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1 Participants
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SECONDARY outcome
Timeframe: Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusionPopulation: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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. Change from Baseline was calculated as post Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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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|---|---|
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Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Baseline, n=7
|
518.83817 Picograms per milliliter
Standard Deviation 269.010355
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Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 0, 0.75 hour, n=6
|
-48.36607 Picograms per milliliter
Standard Deviation 178.371827
|
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Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 0, 4-8 hour, n=6
|
-262.30099 Picograms per milliliter
Standard Deviation 176.415675
|
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Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 1, n=6
|
-214.27224 Picograms per milliliter
Standard Deviation 198.587957
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 2, n=5
|
-91.07498 Picograms per milliliter
Standard Deviation 397.795706
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 30, n=6
|
-215.96831 Picograms per milliliter
Standard Deviation 350.419207
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, Day 90, n=7
|
221.97286 Picograms per milliliter
Standard Deviation 617.906913
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, 6 months, n=7
|
145.05039 Picograms per milliliter
Standard Deviation 846.080946
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
IP-10, 12 months, n=5
|
241.29317 Picograms per milliliter
Standard Deviation 564.374462
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Baseline, n=7
|
175.76865 Picograms per milliliter
Standard Deviation 194.372235
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 0, 0.75 hour, n=6
|
-14.02145 Picograms per milliliter
Standard Deviation 32.535124
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 0, 4-8 hour, n=6
|
-49.28436 Picograms per milliliter
Standard Deviation 54.067623
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 1, n=6
|
-67.61716 Picograms per milliliter
Standard Deviation 61.009544
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 2, n=5
|
-133.99600 Picograms per milliliter
Standard Deviation 165.972042
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 30, n=6
|
-159.17646 Picograms per milliliter
Standard Deviation 207.921389
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, Day 90, n=7
|
-78.69081 Picograms per milliliter
Standard Deviation 227.901113
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, 6 months, n=7
|
-43.68148 Picograms per milliliter
Standard Deviation 325.518838
|
|
Serum Interferon Gamma-induced Protein 10 (IP-10) and Serum Monokine Induced Gamma Interferon (Mig) Levels at Baseline and Change From Baseline Over Time Post Transplant
Mig, 12 months, n=5
|
-30.52711 Picograms per milliliter
Standard Deviation 75.218188
|
SECONDARY outcome
Timeframe: Up to 30 daysPopulation: AP Population
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.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants With Dialysis Events in the First 30 Days Post-transplant
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
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.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants Who Are Dialysis Independent at Visits up to 12 Months Post-transplant
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
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.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)
Any AE
|
7 Participants
|
|
Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)
Any SAE
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
Blood samples were collected to evaluate hematology parameters. Number of participants with abnormality in any hematology parameter results of potential clinical importance (high or low) observed at any time post Baseline are presented. PCI (high or low) was considered if hematocrit (high:\>0.54;low:change from baseline \[CFB\] 0.075 decrease), hemoglobin (high:180; low: CFB 25 decrease), lymphocytes (low: 0.8), neutrophil count (low: 1.5), platelet count (low: 100; high: 550), White blood cells (low: 3; high:20).
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
Lymphocytes, Low
|
7 Participants
|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
Hematocrit, High
|
1 Participants
|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
White Blood Cells, High
|
1 Participants
|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
White Blood Cells, Low
|
1 Participants
|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
Platelet Count, Low
|
1 Participants
|
|
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
Total neutrophils, Low
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
Blood samples were collected to evaluate clinical chemistry parameters. Number of participants with abnormal chemistry results of potential clinical importance (high or low) in any of these parameters at any time post Baseline visit have been presented. PCI (high or low) was considered if albumin (low\<30), calcium (low\<2, high\>2.75), creatinine (high: CHB\>44.2 increase), glucose (low\<3, high\>9), magnesium (low\<0.5, high\>1.23), phosphorus (low\<0.8, high\>1.6), potassium (low\<3, high\>5.5), sodium (low: 130, high\>150), Total carbon dioxide (CO2) (low:18, high\>32), Alanine aminotransferase (ALT) (high\>=2\*upper limit of normal \[ULN\]), Aspartate aminotransferase (AST) (high: \>=2\*ULN), Alkaline phosphatase (ALP) (high:\>=2\*ULN), Total bilirubin (high: \>2\*ULN), Total bilirubin+ALT (high: 1.5\*ULN total bilirubin with \>=2\*ULN ALT).
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Albumin, Low
|
6 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Calcium, Low
|
7 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Glucose, High
|
5 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Potassium, Low
|
1 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Potassium, High
|
3 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Total Bilirubin, High
|
1 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
Sodium, Low
|
2 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
ALT, High
|
1 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
ALP, High
|
1 Participants
|
|
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
AST, High
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
Vital signs parameters included analysis of systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR) and body temperature. Number of participants with any abnormality of potential clinical importance (high or low) in any of these vitals signs at any time post Baseline visit have been presented. PCI (high or low) was considered if SBP (low: \<85, high:\>160), DBP (low: \<45, high\>100), HR (low: \<40, high: \>110) and temperature (low: \<35.5, high: \>37.5).
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
SBP, High
|
5 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
SBP, Low
|
1 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
DBP, High
|
2 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
DBP, Low
|
1 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
HR, High
|
1 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
Temperature, High
|
1 Participants
|
|
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
Temperature, Low
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsPopulation: All Subjects Population
Number of participants having infections were summarized.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Number of Participants Having Infections
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusionPopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Serial blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. PK Population included participants in the 'All Subjects' Population for whom a serum PK sample is obtained and analyzed for GSK1070806.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Serum Concentrations of GSK1070806
Pre-operative, n=7
|
0.0 Nanograms per milliliter
Standard Deviation NA
Standard deviation is not calculated as most of the values at this time point were imputed.
|
|
Serum Concentrations of GSK1070806
0.75 hours, n=6
|
58783.3 Nanograms per milliliter
Standard Deviation 11287.77
|
|
Serum Concentrations of GSK1070806
4-8 hours, n=6
|
60033.3 Nanograms per milliliter
Standard Deviation 13577.43
|
|
Serum Concentrations of GSK1070806
24 hours, n=6
|
50933.3 Nanograms per milliliter
Standard Deviation 12681.11
|
|
Serum Concentrations of GSK1070806
168 hours, n=5
|
28260.0 Nanograms per milliliter
Standard Deviation 9643.29
|
|
Serum Concentrations of GSK1070806
Day 30, n=6
|
17366.7 Nanograms per milliliter
Standard Deviation 6809.60
|
|
Serum Concentrations of GSK1070806
Day 90, n=7
|
5047.0 Nanograms per milliliter
Standard Deviation 2914.37
|
|
Serum Concentrations of GSK1070806
6 months, n=7
|
1083.4 Nanograms per milliliter
Standard Deviation 720.18
|
|
Serum Concentrations of GSK1070806
12 months, n=6
|
19.2 Nanograms per milliliter
Standard Deviation NA
Standard deviation is not calculated as most of the values at this time point were imputed.
|
SECONDARY outcome
Timeframe: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusionPopulation: PK Population
Serial blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. Log-transformed geometric mean and 95% confidence interval have been presented.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Maximum Plasma Concentration (Cmax) of GSK1070806
|
36315.1 Log (nanograms per milliliter)
Interval 10237.6 to 128818.4
|
SECONDARY outcome
Timeframe: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusionPopulation: PK Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
Blood samples were collected to evaluate PK of GSK1070806 at Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion. Log-transformed geometric mean and 95% confidence interval have been presented.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUC[0-t]) and AUC From Time 0 to Infinite Time (AUC[0-inf]) of GSK1070806
AUC (0-t), n=7
|
26131338.2 Log (Hour*nanograms per milliliter)
Interval 8927844.0 to 76485076.9
|
|
Area Under the Plasma Concentration Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUC[0-t]) and AUC From Time 0 to Infinite Time (AUC[0-inf]) of GSK1070806
AUC (0-inf), n=6
|
41032450.7 Log (Hour*nanograms per milliliter)
Interval 28127219.0 to 59858815.6
|
SECONDARY outcome
Timeframe: Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusionPopulation: All Subjects Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
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. Blood samples were collected at indicated time points to assess serum levels of free, total, and GSK1070806 bound IL-18. Baseline value was the latest pre-dose assessment value. Change from Baseline was post Baseline value minus Baseline value.
Outcome measures
| Measure |
GSK1070806 3 mg/kg IV
n=7 Participants
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.
|
|---|---|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Baseline (pre-operative), n=5
|
26.840 Picograms per milliliter
Standard Deviation 37.0569
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 0, 0.75 hour, n=5
|
-22.620 Picograms per milliliter
Standard Deviation 37.1672
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 0, 4-8 hour, n=5
|
-22.540 Picograms per milliliter
Standard Deviation 34.1535
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 1, n=5
|
-23.890 Picograms per milliliter
Standard Deviation 37.0569
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 2, n=4
|
-5.263 Picograms per milliliter
Standard Deviation 14.4846
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 30, n=4
|
-27.925 Picograms per milliliter
Standard Deviation 41.5019
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Free IL-18, Day 90, n=2
|
-2.250 Picograms per milliliter
Standard Deviation 3.1820
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Baseline (pre-operative), n=5
|
21.156 Picograms per milliliter
Standard Deviation 7.5139
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 0, 0.75 hour, n=5
|
362.084 Picograms per milliliter
Standard Deviation 220.2164
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 0, 4-8 hour, n=5
|
314.864 Picograms per milliliter
Standard Deviation 139.1919
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 1, n=5
|
472.204 Picograms per milliliter
Standard Deviation 193.0366
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 2, n=4
|
485.740 Picograms per milliliter
Standard Deviation 252.2876
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 30, n=4
|
617.543 Picograms per milliliter
Standard Deviation 282.9679
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Bound IL-18, Day 90, n=2
|
946.020 Picograms per milliliter
Standard Deviation 21.3971
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Baseline (pre-operative), n=7
|
130.6857 Picograms per milliliter
Standard Deviation 71.37029
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 0, 0.75 hour, n=6
|
572.3333 Picograms per milliliter
Standard Deviation 368.68620
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 0, 4-8 hour, n=6
|
576.3667 Picograms per milliliter
Standard Deviation 273.88543
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 1, n=6
|
636.5667 Picograms per milliliter
Standard Deviation 208.88294
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 2, n=5
|
660.6600 Picograms per milliliter
Standard Deviation 297.32305
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 30, n=6
|
1175.5000 Picograms per milliliter
Standard Deviation 710.48323
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, Day 90, n=7
|
1423.5429 Picograms per milliliter
Standard Deviation 685.42012
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, 6 months, n=7
|
1303.7143 Picograms per milliliter
Standard Deviation 1006.89585
|
|
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
Serum Total IL-18, 12 months, n=6
|
1091.0833 Picograms per milliliter
Standard Deviation 1102.78861
|
SECONDARY outcome
Timeframe: 0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusionPopulation: All Subjects Population. Data was not collected as the immunogenicity samples were not collected for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusionPopulation: All Subjects Population. Data was not collected as the immunogenicity samples were not collected for this terminated indication since healthy volunteers showed low titers and Type 2 Diabetics showed no titers per Investigator's Brochure.
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.
Outcome measures
Outcome data not reported
Adverse Events
GSK1070806 3 mg/kg IV
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GSK1070806 3 mg/kg IV
n=7 participants at risk
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.
|
|---|---|
|
Injury, poisoning and procedural complications
Transplant dysfunction
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
Ureteric obstruction
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Cardiac disorders
Ventricular fibrillation
|
14.3%
1/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
General disorders
Hernia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Immune system disorders
Kidney transplant rejection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Surgical and medical procedures
Ureteral stent removal
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Visceral leishmaniasis
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
End stage renal disease
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
Other adverse events
| Measure |
GSK1070806 3 mg/kg IV
n=7 participants at risk
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.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
57.1%
4/7 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
1/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
42.9%
3/7 • Number of events 3 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Lip swelling
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
71.4%
5/7 • Number of events 5 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
28.6%
2/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Escherichia urinary tract infection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Influenza
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
14.3%
1/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Pyelonephritis acute
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
28.6%
2/7 • Number of events 4 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
Renal disorder
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
Ureteric stenosis
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Blood creatine increased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Blood potassium decreased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Blood sodium decreased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Body temperature decreased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Candida test positive
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Haemoglobin increased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Acidosis
|
14.3%
1/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid overload
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.3%
1/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 2 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
General disorders
Catheter site haemorrhage
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Immune system disorders
Kidney transplant rejection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Nervous system disorders
Tremor
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Bacterial disease carrier
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Nail infection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Pharyngotonsillitis
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Purulent discharge
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Blood glucose increased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Cytomegalovirus test positive
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Investigations
Weight increased
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Renal and urinary disorders
Renal impairment
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural discharge
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Immune system disorders
Transplant rejection
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
|
Product Issues
Product contamination
|
14.3%
1/7 • Number of events 1 • On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.
SAEs and Non-serious AEs were collected for All Subjects Population, comprised of participants who received the dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER