Efficacy and Safety of Sirolimus in Combination With Tacrolimus

University Hospital Muenster

Status and phase

Unknown

Phase 3

Conditions

Kidney Transplantation

Treatments

Drug: Sirolimus

Study type

Interventional

Funder types

Other

NETWORK

Industry

Identifiers

NCT00141804

SirTac 01

contract number DE-02-RG-74

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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