Conditions: Renal Transplantation
Keywords: Everolimus, calcineurine inhibitor, renal transplantation in maintenance, chronic allograft nephropathy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 30

Brief summary:
Efficacy and safety of 2 groups of treatment: everolimus in association with cyclosporine microemulsion and steroids versus everolimus in association with Enteric-coated Mycophenolate Sodium (EC-MPS) and steroids. The study population consists of patients having taken part in study CRAD001A2420 (NCT00154297) until the end (12 months) and having not prematurely discontinued the immunosuppressive regimen received in this study (everolimus + cyclosporine microemulsion + steroids).

Detailed description:

Arms:
arm 1: Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids arm 2: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids

Interventions: intervention 1: Everolimus + Cyclosporine intervention 2: Everolimus + Enteric-coated Mycophenolate Sodium (EC-MPS) intervention 3: Steroids
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: