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

Condition	Intervention	Phase
Kidney Transplantation	Drug: Sirolimus	Phase III

Further Study Details: 

Primary Outcomes: - time to first biopsy proven acute rejection episode at month 12; - graft failure at month 12; - discontinuation of study medication at month 12
Secondary Outcomes: - patient and graft survival at month 12; - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12; - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance); - incidence and severity of infections at month 12; - incidence of adverse events at month 12
Expected Total Enrollment:  190

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 clincical) on tac/rap combinations available.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both

Criteria

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

Germany
      University Hospital Muenster, Muenster,  48149,  Germany

Study chairs or principal investigators

Heiner H. Wolters, Dr. med.,  Principal Investigator,  University Hospital Muenster   

Study ID Numbers:  SirTac 01; contract number DE-02-RG-74
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00141804
Health Authority: Germany: Federal Institute for Drugs and Medicinal Devices
ClinicalTrials.gov processed this record on 2005-09-13