Conditions: Inflammation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 245
Healthy volunteers: no

Brief summary:
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CsA+Rapamune+CS intervention 2: CsA+MMF+CS
Intervention descriptions: intervention 1: Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months intervention 2: The control arm is the standard local practice (official protocol) in Iran:

Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.

Protocol document: