Conditions: Renal Transplantation
Keywords: Renal transplantation, everolimus, calcineurin inhibitors, GFR
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 394
Healthy volunteers: no

Brief summary:
The study is designed to evaluate whether the initiation of everolimus together with the reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in the maintenance of renal transplant recipients with renal impairment by reducing the progression of chronic allograft nephropathy. The development of atherosclerosis in the native arteries of the patients will also be explored.

Detailed description:

Arms:
arm 1: Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids arm 2: Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus(RAD001) 4 mg initial daily dose. arm 3: Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.

Interventions: intervention 1: Everolimus (RAD001) intervention 2: Calcineurin Inhibitors (CNI) intervention 3: Mycophenolate acid (MPA)/Azathioprine (AZA) intervention 4: Steroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: