Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation

NCT01729494 Phase 4 COMPLETED Results posted

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).

Details

Lead sponsor	University of Cincinnati
Phase	Phase 4
Status	COMPLETED
Enrolment	316
Start date	2012-09
Completion	2019-12

Conditions

• Renal Transplantation

Interventions

• Alemtuzumab
• rabbit antithymocyte globulin
• Belatacept
• Tacrolimus
• Mycophenolate mofetil
• early cessation of steroids

Primary outcomes

• # Patients With Composite Endpoint of Experiencing Either Death, Graft Loss, or eGFR < 45ml/Min — 12 months
  Number of Patients that experienced patient Death or Graft Loss or had an estimated GFR (eGFR) (MDRD) \< 45 mL/min

Countries

United States