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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
First Posted : September 1, 2005
Last Update Posted : December 1, 2005
Sponsor:
Collaborators:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment Phase
Kidney Transplantation Drug: Sirolimus Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2002
Estimated Study Completion Date : June 2005

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. - time to first biopsy proven acute rejection episode at month 12
  2. - graft failure at month 12
  3. - discontinuation of study medication at month 12

Secondary Outcome Measures :
  1. - patient and graft survival at month 12
  2. - incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
  3. - Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
  4. - incidence and severity of infections at month 12
  5. - incidence of adverse events at month 12

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00141804


Locations
Germany
University Hospital Muenster
Muenster, Germany, 48149
Sponsors and Collaborators
University Hospital Muenster
Proverum GmbH
KKS Netzwerk
Fujisawa GmbH
Investigators
Principal Investigator: Heiner H. Wolters, Dr. med. University Hospital Muenster
More Information

ClinicalTrials.gov Identifier: NCT00141804     History of Changes
Other Study ID Numbers: SirTac 01
contract number DE-02-RG-74
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: August 2005

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

Additional relevant MeSH terms:
Tacrolimus
Sirolimus
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents