A Randomized, Multicenter Study of Belatacept, Everolimus, rATG and Early Steroid Withdrawal Versus Belatacept, Mycophenolate, rATG and Chronic Steroids in Renal Transplantation (BETTER)

NCT04849533 Phase 4 UNKNOWN

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).

Details

Lead sponsor	University of Cincinnati
Phase	Phase 4
Status	UNKNOWN
Enrolment	120
Start date	2021-04-09
Completion	2024-07

Conditions

• Kidney Transplant Rejection

Interventions

• Belatacept
• Everolimus
• mycophenolate mofetil
• corticosteroids
• rabbit antithymocyte globulin

Primary outcomes

• Composite endpoint of patient death, graft loss, or eGFR (MDRD) < 45ml/min mL/min/1.73m2 — 12 months
  Number of subjects with composite endpoint of either 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).

Countries

United States