Efficacy and Safety of Sirolimus in Combination With Tacrolimus - Full Text View

Sponsors and Collaborators:	University Hospital Muenster Proverum GmbH Koordinierungszentrum für Klinische Studien Fujisawa GmbH
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00141804

Purpose

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	Intervention	Phase
Kidney Transplantation	Drug: Sirolimus	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:

- time to first biopsy proven acute rejection episode at month 12
- graft failure at month 12
- discontinuation of study medication at month 12

Secondary Outcome Measures:

- patient and graft survival at month 12
- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
- incidence and severity of infections at month 12
- incidence of adverse events at month 12

Estimated Enrollment:	190
Study Start Date:	January 2002
Estimated Study Completion Date:	June 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141804

Locations

Germany
University Hospital Muenster
Muenster, Germany, 48149

Sponsors and Collaborators

University Hospital Muenster

Proverum GmbH

Koordinierungszentrum für Klinische Studien

Fujisawa GmbH

Investigators

Principal Investigator:

Heiner H. Wolters, Dr. med.

University Hospital Muenster

More Information

Study ID Numbers:	SirTac 01, contract number DE-02-RG-74
Study First Received:	August 31, 2005
Last Updated:	November 30, 2005
ClinicalTrials.gov Identifier:	NCT00141804
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

renal transplantation
immunosuppression
prevention of acute rejection

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Miconazole
Tioconazole
Tacrolimus

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Antifungal Agents

Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009