kidney transplant kidney kidney transplant
Conditions
Interventions
Group 1: Convert to Belatacept in doses of 5 mg/kg intravenous
Group 2: Continue established CNI treatment twice daily doses by mouth as
directed
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Men and women, ages 18 -75 inclusive 2) Adult recipients of a renal allograft from a living donor or a deceased donor between 6-36 months prior to enrollment 3) Receiving a stable regimen of CNI (CsA or TAC) on a background regimen of MMF or MPA, with concomitant daily corticosteroids for * 1 calender month prior to randomization. 4) cGFR * 30 and * 75 mL/min/1.73 m2 (Modification of Diet in Renal Disease study [MDRD] 7-point formula). Subjects with cGFR > 60 ml/min/1.73m2 must have evidence of CNI toxicity (eg, renal, neurologic, hematologic or cardiovascular/metabolic causes). 5) Stable renal function within 3 months prior to enrollment (as defined by one local laboratory serum creatinine value ± 10% of the local laboratory screening value)
Exclusion criteria
Exclusion criteria: 1) Recipients with EBV serostatus negative or unknown 2) History of acute rejection (AR) within 3 months prior to enrollment 3) History of positive donor specific antibodies (DSA) 4) History of antibody mediated rejection 5) Positive T-cell lymphocytotoxic cross match 6) Proteinuria >1 g/day or > 0.5 g/day if diabetic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who survive with a functional graft at 24 months post randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Patient and Graft Survival * Proportion of subjects who survive with a functional graft at 12 months post-randomization * Acute Rejection * The incidence and severity of clinically suspected, biopsy-proven acute rejection at 12 and 24 months post- randomization * Renal Function * Mean change in cGFR (per 4-variable MDRD equation) from baseline to 12 and 24 months post-randomization (% and absolute) * Slopes of cGFR and 1/serum creatinine respectively from baseline as well as Month 3 to 12 and 24 months post-randomization * Proportion of subjects with > 5% and > 10% improvement over baseline in cGFR at 12 and 24 months post randomization * Urine protein/ creatinine ratio (UPCR) at baseline, 3, 6, 12, and 24 months post randomization * Hypertension * Mean change in systolic and diastolic blood pressure from baseline to 12 and 24 months post randomization, and intensity of anti-hypertensive treatment regimens at 12 and 24 months. * Donor Specific Antibodies * Incidence of de novo donor specific antibodies at Day 1, 12 and 24 months post-randomization * Safety and tolerability of a belatacept-based immunosuppressive regimen * All adverse events * Adverse events of special interest * Clinically significant changes in vital signs * Laboratory test abnormalities * Clinical tolerability of the drug | — |
Countries
Netherlands
Outcome results
None listed