NCT00141804

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 190 (planned)
• Sponsor: University Hospital Muenster · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Sirolimus

Timeline

• Start date: 2002-01-01
• Completion: 2005-06-01
• First posted: 2005-09-01
• Last updated: 2005-12-01

Locations

1 site across 1 country: Germany