Overview

Belatacept Early Steroid Withdrawal Trial

Status:
Completed
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
The study purpose is to determine the safety and efficacy of a belatacept-based immunosuppressive regimen (calcineurin inhibitor free) with alemtuzumab or rabbit antithymocyte globulin (rATG) induction and early glucocorticoid withdrawal (CSWD) and a belatacept-based immunosuppressive regimen with tacrolimus-based regimen with rabbit antithymocyte globulin induction and early glucocorticoid withdrawal in renal transplant recipients. The hypothesis is that a belatacept-based immunosuppressive regimen with alemtuzumab induction, mycophenolate mofetil (MMF)/mycophenolic acid (MPA), and early glucocorticoid withdrawal (Group A) in renal transplant recipients or Belatacept-based immunosuppressive regimen with rabbit antithymocyte globulin induction, MMF/MPA and early glucocorticoid withdrawal (Group B) will lead to less risk of graft loss, patient death, or reduced renal function at 12 months as compared to a tacrolimus-based immunosuppressive regimen with rabbit antithymocyte globulin, MMF/MPA, and early glucocorticoid withdrawal in renal transplant recipients (Group C).
Phase:
Phase 4
Details
Lead Sponsor:
University of Cincinnati
Treatments:
Abatacept
Alemtuzumab
Antilymphocyte Serum
Methylprednisolone
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Tacrolimus
Thymoglobulin