57
Participants
Start Date
June 30, 2014
Primary Completion Date
December 31, 2016
Study Completion Date
December 31, 2016
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."
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)"
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)"
rATG
"1.5 mg/kg IV daily on Day 0-3.~(standard of care)"
Methylprednisolone
"500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3.~(standard of care)"
Renal transplant
Standard organ transplant of a kidney into a patient with end-stage renal disease.
Columbia University Medical Center, New York
Columbia University
OTHER