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Efficacy and Safety of Sirolimus in Combination With Tacrolimus

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by University Hospital Muenster.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Proverum GmbH
Koordinierungszentrum für Klinische Studien
Fujisawa GmbH
Information provided by:
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00141804
First received: August 31, 2005
Last updated: November 30, 2005
Last verified: August 2005
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided

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

Keywords provided by University Hospital Muenster:
renal transplantation
immunosuppression
prevention of acute rejection

Additional relevant MeSH terms:
Sirolimus
Everolimus
Tacrolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
 Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on June 17, 2013