Clinical trial NCT02152345
Conditions: Implant or Graft; Rejection
Keywords: kidney renal transplant belatacept delayed graft function thymoglobulin tacrolimus kidney function immunosuppression NGAL
Sponsor: Columbia University
Start date: 2014-06-01; Completion date: 2016-12-31
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of this study is to ﬁnd out whether treatment to prevent kidney rejection with belatacept in presence of Thymoglobulin induction and withdrawal of steroids will result in less delayed graft function or "sleepy kidney" after transplant than that seen in patients who get tacrolimus as their main drug to prevent rejection instead of belatacept. The investigators will also look at whether patients who get belatacept have the same, lesser or more problems that those who get tacrolimus.

Detailed description:
New York Presbyterian Hospital-Columbia University Medical Center (NYPH-CUMC) performs nearly 250 renal transplants annually; of these approximately half are recipients of a variety of deceased donor kidneys, usually with cold ischemia time (CIT) \>24 hours leading to an approximate incidence of delayed graft function (DGF) of 50%. The main focus of this study will be to determine whether initial immunosuppression with belatacept with Thymoglobulin induction will result in lower incidence and/or more rapid disappearance of DGF than that observed in patients who receive tacrolimus based immunosuppression. NGAL determinations will bne made in the first months after transplantation to correlate with clinical DGF.

Arms: arm 1: Renal transplant recipients will receive steroids (Methylprednisolone), rATG, Belatacept and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation. arm 2: Renal transplant recipients will receive standard immunosuppressive therapy, including steroids (Methylprednisolone), rATG, Tacrolimus and Mycophenolate. Subjects will be followed for primary endpoint to Day 7 and Month 3 after transplantation and secondary endpoints of kidney function and patient and graft survival up to month 36 after transplantation.
Interventions: intervention 1: Belatacept intervention 2: Tacrolimus intervention 3: Mycophenolate intervention 4: rATG intervention 5: Methylprednisolone intervention 6: Renal transplant
Intervention descriptions: intervention 1: Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84.

Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study. intervention 2: Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180.

Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study.

(standard of care) intervention 3: An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.

720 mg by mouth every 12 hours (Day 0)(1080 mg AA).

(standard of care) intervention 4: 1.5 mg/kg IV daily on Day 0-3.

(standard of care) intervention 5: 500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3.

(standard of care) intervention 6: Standard organ transplant of a kidney into a patient with end-stage renal disease.

Protocol documents: