Status:
UNKNOWN
Efficacy and Safety of Sirolimus in Combination With Tacrolimus
Lead Sponsor:
University Hospital Muenster
Collaborating Sponsors:
Proverum GmbH
KKS Netzwerk
Conditions:
Kidney Transplantation
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
End Date :
June 1 2005
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT00141804
Start Date
January 1 2002
End Date
June 1 2005
Last Update
December 1 2005
Active Locations (1)
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1
University Hospital Muenster
Münster, Germany, 48149