Efficacy and Safety of Sirolimus in Combination With Tacrolimus
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ClinicalTrials.gov Identifier: NCT00141804
Recruitment Status : Unknown
Verified August 2005 by University Hospital Muenster. Recruitment status was: Active, not recruiting
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 or disease
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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
first kidney 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
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