Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

PHASE4CompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2016

Conditions
Implant or Graft; Rejection
Interventions
DRUG

Belatacept

"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."

DRUG

Tacrolimus

"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)"

DRUG

Mycophenolate

"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)"

DRUG

rATG

"1.5 mg/kg IV daily on Day 0-3.~(standard of care)"

DRUG

Methylprednisolone

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

PROCEDURE

Renal transplant

Standard organ transplant of a kidney into a patient with end-stage renal disease.

Trial Locations (1)

10032

Columbia University Medical Center, New York

All Listed Sponsors
lead

Columbia University

OTHER

NCT02152345 - Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients | Biotech Hunter | Biotech Hunter