A Phase 2 interventional study of GSK1070806 and 1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids in Kidney Transplantation (Status Post), sponsored by GlaxoSmithKline. Terminated at 4 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-06-26.
Sponsored by GlaxoSmithKline · Phase 2, Interventional, and Treatment
This is a phase 2 study to evaluate the efficacy, safety, tolerability and pharmacokinetics of GSK1070806 in subjects undergoing renal transplantation. GSK1070806 is an anti-interleukin 18 (IL18) monoclonal antibody, which binds to IL-18 and inhibits signaling through the IL-18 receptor. Recipients of donor kidneys, retrieved after circulatory death of the donor, will be administered a single intravenous infusion of GSK1070806 to test whether inhibition of IL-18 can reduce the rate of Delayed Graft Function (DGF) and graft rejection. Subjects will be followed for 12 months post dose/transplant. Up to 40 adult subjects will be enrolled in this study.
83 studies on the registry are indexed under Delayed Graft Function; 15 are open to participants now.
This study's enrollment of 7 is below the median of 90 across 62 interventional studies indexed under Delayed Graft Function.
Browse Delayed Graft Function studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Male and Female:
Females:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects received a single dose of 3 milligram per kilogram (mg/kg) intravenous (IV) infusion of GSK1070806 administered prior to kidney allograft reperfusion. Subjects also received a combination immunosuppression comprized of basiliximab; mycophenolate mofetil (MMF) or aziothioprine; tacrolimus; and corticosteroids based on the clinical judgment of the investigator.
Biological: GSK1070806 · Drug: 1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids
Injectable solution of 100 milligram/millilitre (mg/mL), administered as a single dose of 3 milligram/kilogram (mg/kg) (maximum of 10 mg/kg) diluted in 100 mL sterile IV infusion bag of 0.9% Sodium Chloride.
This immunosuppressant regimen may be revised based on the clinical judgment of the investigator including titration of tacrolimus levels.
Number of Participants Requiring Dialysis During the First 7 Days Post Transplant
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.
Time frame: Up to Day 7
Serum Creatinine at Baseline and Change From Baseline Over Time Post Transplant
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.
Time frame: Baseline and up to 12 months
Urine Volume at Baseline and Change From Baseline Over Time Post Transplant
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.
Time frame: Baseline (Pre-operative) and up to Day 28
Number of Participants in the First 7 Days With: Primary Non Function, Functional DGF, Intermediate Graft Function, Immediate Graft Function
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.
Time frame: Up to Day 7
Number of Participants With Episodes of Biopsy-proven Acute Rejection
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.
Time frame: Up to 12 months
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
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.
Time frame: Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion
Number of Participants With Dialysis Events in the First 30 Days Post-transplant
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.
Time frame: Up to 30 days
Number of Participants Who Are Dialysis Independent at Visits up to 12 Months Post-transplant
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.
Time frame: Up to 12 months
Number of Participants With Adverse Event (AE) and Serious Adverse Event (SAE)
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.
Time frame: Up to 12 months
Number of Participants Having Any Abnormality in Hematology Results of Potential Clinical Importance
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).
Time frame: Up to 12 months
Number of Participants Having Any Abnormal Clinical Chemistry Results of Potential Clinical Importance
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).
Time frame: Up to 12 months
Number of Participants Having Any Abnormality of Potential Clinical Importance of Vital Signs Results
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).
Time frame: Up to 12 months
Number of Participants Having Infections
Number of participants having infections were summarized.
Time frame: Up to 12 months
Serum Concentrations of GSK1070806
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.
Time frame: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion
Maximum Plasma Concentration (Cmax) of GSK1070806
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.
Time frame: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion
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
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.
Time frame: Pre-operative, 0.75 hours, 4-8 hours, 24 hours, 168 hours, Day 30, Day 90, 6 months and 12 months after kidney reperfusion
Baseline and Change From Baseline in Serum Levels of Free, Total, and GSK1070806 Bound Interleukin 18 (IL-18) Over Time Post-transplant
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.
Time frame: Baseline and at 0.75 hours, 4-8 hours, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion
Number of Participants With Positive Result in Anti-GSK1070806 Antibodies (ADAs)
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.
Time frame: 0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion
ADA Titer Before and After GSK1070806 Administration
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.
Time frame: 0.75 hour and 4-8 hour on Day 0, Day 1, Day 2, Day 30, Day 90, 6 months and 12 months post reperfusion
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.
| Milestone | GSK1070806 3 mg/kg IV |
|---|---|
| Started | 7 |
| Completed | 6 |
| Not completed | 1 |
| Withdrew: Lost to follow-up | 1 |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Number of Participants Requiring Dialysis During the First 7 Days Post Transplant | 4 |
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.
| Micromoles per liter | GSK1070806 3 mg/kg IV |
|---|---|
| Screening, n=7 | 679.0 ± 175.14 |
| Day 0, n=7 | -39.3 ± 160.09 |
| Day 1, n=7 | -44.7 ± 214.06 |
| Day 2, n=7 | -99.0 ± 304.29 |
| Day 3, n=7 | -36.7 ± 378.28 |
| Day 4, n=7 | -104.6 ± 378.79 |
| Day 5, n=6 | -57.2 ± 334.19 |
| Day 6, n=6 | -75.7 ± 308.22 |
| Day 7, n=6 | -43.5 ± 321.91 |
| Day 8, n=5 | -150.8 ± 293.48 |
| Day 9, n=3 | -24.0 ± 297.82 |
| Day 10, n=3 | -53.0 ± 395.94 |
| Day 11, n=3 | -97.0 ± 462.46 |
| Day 12, n=2 | 110.0 ± 257.39 |
| Day 13, n=2 | 38.0 ± 209.30 |
| Day 14, n=2 | 4.0 ± 190.92 |
| Day 15, n=2 | -51.0 ± 172.53 |
| Day 16, n=2 | -61.5 ± 173.24 |
| Day 17, n=2 | -107.5 ± 143.54 |
| Day 18, n=2 | -145.0 ± 123.04 |
| Day 19, n=2 | -173.5 ± 95.46 |
| Day 20, n=2 | -183.5 ± 81.32 |
| Day 21, n=1 | -117.0 ± NA |
| Day 22, n=1 | -91.0 ± NA |
| Day 23, n=1 | -95.0 ± NA |
| Day 24, n=1 | -115.0 ± NA |
| Day 25, n=1 | -152.0 ± NA |
| Day 26, n=1 | -155.0 ± NA |
| Day 27, n=1 | -175.0 ± NA |
| Day 28, n=1 | -191.0 ± NA |
| Day 30, n=7 | -478.3 ± 225.47 |
| Day 90, n=7 | -489.9 ± 214.06 |
| 6 months, n=7 | -467.4 ± 232.49 |
| 12 months, n=6 | -490.5 ± 224.32 |
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.
| Liter | GSK1070806 3 mg/kg IV |
|---|---|
| Baseline (Pre-operative), n=5 | 0.6700 ± 0.60581 |
| Day 0, n=4 | -0.5150 ± 0.59533 |
| Day 1, n=5 | 0.5862 ± 1.56917 |
| Day 2, n=5 | 1.2820 ± 2.62989 |
| Day 3, n=5 | 0.8840 ± 1.04040 |
| Day 4, n=5 | 1.1480 ± 1.00442 |
| Day 5, n=4 | 0.8270 ± 1.02297 |
| Day 6, n=4 | 1.1168 ± 1.30252 |
| Day 7, n=4 | 1.2985 ± 1.37212 |
| Day 8, n=3 | 1.2090 ± 1.20354 |
| Day 9, n=2 | 1.2135 ± 1.46866 |
| Day 10, n=2 | 0.8585 ± 0.62720 |
| Day 11, n=2 | 0.4985 ± 0.22840 |
| Day 12, n=1 | 1.4000 ± NA |
| Day 13, n=1 | 1.6900 ± NA |
| Day 14, n=1 | 1.1800 ± NA |
| Day 15, n=1 | 1.5500 ± NA |
| Day 16, n=1 | 1.8500 ± NA |
| Day 17, n=1 | 1.5000 ± NA |
| Day 18, n=1 | 1.9000 ± NA |
| Day 19, n=1 | 1.6000 ± NA |
| Day 20, n=1 | 1.2500 ± NA |
| Day 21, n=1 | 0.7500 ± NA |
| Day 22, n=1 | 1.0500 ± NA |
| Day 23, n=1 | 1.1500 ± NA |
| Day 24, n=1 | 1.4500 ± NA |
| Day 25, n=1 | 2.0500 ± NA |
| Day 26, n=1 | 2.0000 ± NA |
| Day 27, n=1 | 1.5500 ± NA |
| Day 28, n=1 | 1.4600 ± NA |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Primary Non Function | 1 |
| 3 day Functional DGF | 3 |
| 7 day Functional DGF | 5 |
| 3 day Intermediate Graft Function | 0 |
| 7 day Intermediate Graft Function | 1 |
| 3 day Immediate Graft Function | 1 |
| 7 day Immediate Graft Function | 0 |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Number of Participants With Episodes of Biopsy-proven Acute Rejection | 1 |
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.
| Picograms per milliliter | GSK1070806 3 mg/kg IV |
|---|---|
| IP-10, Baseline, n=7 | 518.83817 ± 269.010355 |
| IP-10, Day 0, 0.75 hour, n=6 | -48.36607 ± 178.371827 |
| IP-10, Day 0, 4-8 hour, n=6 | -262.30099 ± 176.415675 |
| IP-10, Day 1, n=6 | -214.27224 ± 198.587957 |
| IP-10, Day 2, n=5 | -91.07498 ± 397.795706 |
| IP-10, Day 30, n=6 | -215.96831 ± 350.419207 |
| IP-10, Day 90, n=7 | 221.97286 ± 617.906913 |
| IP-10, 6 months, n=7 | 145.05039 ± 846.080946 |
| IP-10, 12 months, n=5 | 241.29317 ± 564.374462 |
| Mig, Baseline, n=7 | 175.76865 ± 194.372235 |
| Mig, Day 0, 0.75 hour, n=6 | -14.02145 ± 32.535124 |
| Mig, Day 0, 4-8 hour, n=6 | -49.28436 ± 54.067623 |
| Mig, Day 1, n=6 | -67.61716 ± 61.009544 |
| Mig, Day 2, n=5 | -133.99600 ± 165.972042 |
| Mig, Day 30, n=6 | -159.17646 ± 207.921389 |
| Mig, Day 90, n=7 | -78.69081 ± 227.901113 |
| Mig, 6 months, n=7 | -43.68148 ± 325.518838 |
| Mig, 12 months, n=5 | -30.52711 ± 75.218188 |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Number of Participants With Dialysis Events in the First 30 Days Post-transplant | 5 |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Number of Participants Who Are Dialysis Independent at Visits up to 12 Months Post-transplant | 2 |
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.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Any AE | 7 |
| Any SAE | 6 |
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).
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Lymphocytes, Low | 7 |
| Hematocrit, High | 1 |
| White Blood Cells, High | 1 |
| White Blood Cells, Low | 1 |
| Platelet Count, Low | 1 |
| Total neutrophils, Low | 1 |
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).
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Albumin, Low | 6 |
| Calcium, Low | 7 |
| Glucose, High | 5 |
| Potassium, Low | 1 |
| Potassium, High | 3 |
| Total Bilirubin, High | 1 |
| Sodium, Low | 2 |
| ALT, High | 1 |
| ALP, High | 1 |
| AST, High | 1 |
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).
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| SBP, High | 5 |
| SBP, Low | 1 |
| DBP, High | 2 |
| DBP, Low | 1 |
| HR, High | 1 |
| Temperature, High | 1 |
| Temperature, Low | 2 |
Number of participants having infections were summarized.
| Participants | GSK1070806 3 mg/kg IV |
|---|---|
| Number of Participants Having Infections | 5 |
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.
| Nanograms per milliliter | GSK1070806 3 mg/kg IV |
|---|---|
| Pre-operative, n=7 | 0.0 ± NA |
| 0.75 hours, n=6 | 58783.3 ± 11287.77 |
| 4-8 hours, n=6 | 60033.3 ± 13577.43 |
| 24 hours, n=6 | 50933.3 ± 12681.11 |
| 168 hours, n=5 | 28260.0 ± 9643.29 |
| Day 30, n=6 | 17366.7 ± 6809.60 |
| Day 90, n=7 | 5047.0 ± 2914.37 |
| 6 months, n=7 | 1083.4 ± 720.18 |
| 12 months, n=6 | 19.2 ± NA |
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.
| Log (nanograms per milliliter) | GSK1070806 3 mg/kg IV |
|---|---|
| Maximum Plasma Concentration (Cmax) of GSK1070806 | 36315.1 (10237.6 to 128818.4) |
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.
| Log (Hour*nanograms per milliliter) | GSK1070806 3 mg/kg IV |
|---|---|
| AUC (0-t), n=7 | 26131338.2 (8927844.0 to 76485076.9) |
| AUC (0-inf), n=6 | 41032450.7 (28127219.0 to 59858815.6) |
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.
| Picograms per milliliter | GSK1070806 3 mg/kg IV |
|---|---|
| Serum Free IL-18, Baseline (pre-operative), n=5 | 26.840 ± 37.0569 |
| Serum Free IL-18, Day 0, 0.75 hour, n=5 | -22.620 ± 37.1672 |
| Serum Free IL-18, Day 0, 4-8 hour, n=5 | -22.540 ± 34.1535 |
| Serum Free IL-18, Day 1, n=5 | -23.890 ± 37.0569 |
| Serum Free IL-18, Day 2, n=4 | -5.263 ± 14.4846 |
| Serum Free IL-18, Day 30, n=4 | -27.925 ± 41.5019 |
| Serum Free IL-18, Day 90, n=2 | -2.250 ± 3.1820 |
| Serum Bound IL-18, Baseline (pre-operative), n=5 | 21.156 ± 7.5139 |
| Serum Bound IL-18, Day 0, 0.75 hour, n=5 | 362.084 ± 220.2164 |
| Serum Bound IL-18, Day 0, 4-8 hour, n=5 | 314.864 ± 139.1919 |
| Serum Bound IL-18, Day 1, n=5 | 472.204 ± 193.0366 |
| Serum Bound IL-18, Day 2, n=4 | 485.740 ± 252.2876 |
| Serum Bound IL-18, Day 30, n=4 | 617.543 ± 282.9679 |
| Serum Bound IL-18, Day 90, n=2 | 946.020 ± 21.3971 |
| Serum Total IL-18, Baseline (pre-operative), n=7 | 130.6857 ± 71.37029 |
| Serum Total IL-18, Day 0, 0.75 hour, n=6 | 572.3333 ± 368.68620 |
| Serum Total IL-18, Day 0, 4-8 hour, n=6 | 576.3667 ± 273.88543 |
| Serum Total IL-18, Day 1, n=6 | 636.5667 ± 208.88294 |
| Serum Total IL-18, Day 2, n=5 | 660.6600 ± 297.32305 |
| Serum Total IL-18, Day 30, n=6 | 1175.5000 ± 710.48323 |
| Serum Total IL-18, Day 90, n=7 | 1423.5429 ± 685.42012 |
| Serum Total IL-18, 6 months, n=7 | 1303.7143 ± 1006.89585 |
| Serum Total IL-18, 12 months, n=6 | 1091.0833 ± 1102.78861 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over On-treatment serious adverse events (SAEs) and non-serious AEs were defined as events occurring from the first dose until 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GSK1070806 3 mg/kg IV | 0/7 (0%) | 6/7 (85.7%) | 7/7 (100%) |
| Event | GSK1070806 3 mg/kg IV |
|---|---|
| PneumoniaInfections and infestations | 1/7 |
| Urinary tract infectionInfections and infestations | 1/7 |
| Ventricular fibrillationCardiac disorders | 1/7 |
| HerniaGeneral disorders | 1/7 |
| Kidney transplant rejectionImmune system disorders | 1/7 |
| Transplant dysfunctionInjury, poisoning and procedural complications | 1/7 |
| Ureteric obstructionRenal and urinary disorders | 1/7 |
| ProstatomegalyReproductive system and breast disorders | 1/7 |
| Respiratory arrestRespiratory, thoracic and mediastinal disorders | 1/7 |
| Ureteral stent removalSurgical and medical procedures | 1/7 |
| Event | GSK1070806 3 mg/kg IV |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 5/7 |
| ConstipationGastrointestinal disorders | 4/7 |
| DiarrhoeaGastrointestinal disorders | 3/7 |
| NauseaGastrointestinal disorders | 2/7 |
| ThrombocytopeniaBlood and lymphatic system disorders | 2/7 |
| Urinary tract infectionInfections and infestations | 2/7 |
| Urinary retentionRenal and urinary disorders | 2/7 |
| HypertensionVascular disorders | 2/7 |
| Abdominal painGastrointestinal disorders | 1/7 |
| DyspepsiaGastrointestinal disorders | 1/7 |
| Age, Continuous(Years) | GSK1070806 3 mg/kg IV |
|---|---|
| Mean | 58.7 ± 13.46 |
| Sex: Female, Male(Participants) | GSK1070806 3 mg/kg IV |
|---|---|
| Female | 0 |
| Male | 7 |
| Race/Ethnicity, Customized(Participants) | GSK1070806 3 mg/kg IV |
|---|---|
| White | 7 |
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Plan to share: Yes
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Studies of the drug tested here: GSK1070806