Efficacy and Safety of Sirolimus in Combination With Tacrolimus

Kidney Transplantation Clinical Trial

Official title:

A Randomized Multicenter Study to Compare Tacrolimus and MMF With Tacrolimus and Rapamycin in Patients After Renal Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00141804
• Other study ID #: SirTac 01
• Secondary ID: contract number
• Status: Active, not recruiting
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: November 30, 2005
• Start date: January 2002
• Est. completion date: June 2005

Study information

• Verified date: August 2005
• Source: University Hospital Muenster
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 190
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Sirolimus

Locations

Country	Name	City	State
Germany	University Hospital Muenster	Muenster

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital Muenster	Fujisawa GmbH, KKS Netzwerk, Proverum GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- time to first biopsy proven acute rejection episode at month 12
Primary	- graft failure at month 12
Primary	- discontinuation of study medication at month 12
Secondary	- patient and graft survival at month 12
Secondary	- incidence and severity of biopsy proven acute rejection episodes and incidence of steroid-resistant acute rejection episodes at month 12
Secondary	- Renal function at month 12 (S-creatinine, Cockgroft-Gault clearance)
Secondary	- incidence and severity of infections at month 12
Secondary	- incidence of adverse events at month 12