Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)
Status:
Recruiting
Trial end date:
2024-07-01
Target enrollment:
Participant gender:
Summary
This study is designed to determine the safety and efficacy of two calcineurin inhibitor free
treatment groups 1) a belatacept, everolimus and early corticosteroid withdrawal (ECSWD)
immunosuppressive regimen with rabbit antithymocyte globulin induction (rATG) and 2) a
belatacept, mycophenolate, chronic steroid regimen with rATG and compare to historical
controls of tacrolimus-based and belatacept-based regimens in combination with rATG
induction, mycophenolate, and ESWD in renal transplant recipients.
The purpose is to evaluate the effect of 2 regimens (rATG
induction/belatacept/everolimus/ESWD and rATG induction/belatacept/mycophenolate/CS) on the
composite of patient death, graft loss, or eGFR (MDRD) < 45 mL/min/1.73m2 at Month 12
post-transplantation compared to historical controls of the BEST Trial (groups B and C).