Study Comparing Conversion From Calcineurin Inhibitors to Rapamune Versus Standard Therapy in Established Renal Allograft Recipients

Phase 3

Completed

• Conditions: Graft Rejection; Kidney Failure; Kidney Transplantation

• Registration Number: NCT00273871
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of the study is to determine the effect of conversion from calcineurin inhibitor based therapy to Rapamune based therapy in patients with mild to moderate renal insufficiency.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-01
• Study First Submitted: 2006-01-05
• Study First Submitted QC: 2006-01-05
• Study First Posted: 2006-01-09
• Study Completion: 2006-09
• Status Verified: 2007-05
• Last Update Submitted: 2011-03-07
• Last Update Posted: 2011-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

• Age over 18
• Treatment with a calcineurin inhibitor
• Patients with mild to moderate renal insufficiency

Exclusion Criteria

• Patients with acute rejection
• Patients who received a transplant more than 10 years ago

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference between treatment groups in renal function at 12 months.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute rejection, patient and graft survival at 12 months, labs and physical examinations, quality of life etc.