Trial | NCT00141804  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    sirolimus ...

  • Study Participants

    190
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.
Study Started
Jan 31
2002
Study Completion
Jun 30
2005
Last Update
Dec 01
2005
Estimate

Drug Sirolimus

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
No Results Posted