Conditions: Kidney Transplantation
Keywords: Treatment Effectiveness Treatment Efficacy Anti-rejection therapy Immunosuppression Therapy, antirejection Renal Transplantation Transplantation, Kidney Transplantation, Renal Grafting, Kidney
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 501
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

Detailed description:
A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Arms:
arm 1: Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American arm 2: Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American arm 3: Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American arm 4: Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody \< 20% and first transplant and non-African American

Interventions: intervention 1: basiliximab intervention 2: rabbit anti-thymocyte globulin intervention 3: tacrolimus intervention 4: alemtuzumab intervention 5: mycophenolate mofetil intervention 6: steroids
Intervention descriptions: intervention 1: IV intervention 2: IV intervention 3: oral intervention 4: Intravenous (IV) intervention 5: oral intervention 6: IV and/or oral

Protocol document: