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
KKS Netzwerk
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

August 31, 2005
November 30, 2005
January 2002
Not Provided
  • - time to first biopsy proven acute rejection episode at month 12
  • - graft failure at month 12
  • - discontinuation of study medication at month 12
Same as current
Complete list of historical versions of study NCT00141804 on ClinicalTrials.gov Archive Site
  • - 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
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Sirolimus in Combination With Tacrolimus
A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
Drug: Sirolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
190
June 2005
Not Provided

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00141804
SirTac 01, contract number DE-02-RG-74
Not Provided
Not Provided
University Hospital Muenster
  • Proverum GmbH
  • KKS Netzwerk
  • Fujisawa GmbH
Principal Investigator: Heiner H. Wolters, Dr. med. University Hospital Muenster
University Hospital Muenster
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP