Efficacy and Safety of Sirolimus in Combination With Tacrolimus

A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

Basic randomized clinical trial (multicentre) in primary KTX to assess the safety and efficacy of a tac/rapa vs a tac/MMF regimen. Tac trough levels in accordance with current standards in both arms. Steroids to be used to individual centre protocol. Rapa trough levels will be adjusted to 5-10 ng/ml. Up to now only few data (primate and clinical) on tac/rap combinations available.

Inclusion Criteria:

• first kidney transplantation
• re-transplantation
• non-related living donor transplantation
• patients > 18 years
• patients have given their written consent after being informed
• female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

Exclusion Criteria:

• related living donation
• patients with known HIV-anamnesis
• patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection
• patients with present malignant disease
• patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer
• patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority
• other reasons which depend on the assessment of the physician