This trial is active, not recruiting.

Condition kidney transplantation
Treatment sirolimus
Phase phase 3
Target mTOR
Sponsor University Hospital Muenster
Collaborator Proverum GmbH
Start date January 2002
End date June 2005
Trial size 190 participants
Trial identifier NCT00141804, SirTac 01, contract number DE-02-RG-74


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention

Primary Outcomes

- time to first biopsy proven acute rejection episode at month 12
time frame:
- graft failure at month 12
time frame:
- discontinuation of study medication at month 12
time frame:

Secondary Outcomes

- patient and graft survival at month 12
time frame:
- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
time frame:
- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
time frame:
- incidence and severity of infections at month 12
time frame:
- incidence of adverse events at month 12
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation
Principal investigator Heiner H. Wolters, Dr. med.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2005.
Information provided to ClinicalTrials.gov by University Hospital Muenster.