Study Evaluating Sirolimus in the Treatment of Kidney Transplant

Phase 4

Completed

• Conditions: Kidney Failure; Kidney Diseases

• Registration Number: NCT00282217
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The aim of this study is to test whether withdrawal of calcineurin inhibitors, followed by treatment with sirolimus, may improve renal function in renal transplant recipients with chronic allograft nephropathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-24
• Study First Submitted QC: 2006-01-24
• Study First Posted: 2006-01-25
• Study Start: 2006-08
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-21
• Last Update Posted: 2007-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Renal transplantation
• Biopsy-confirmed chronic rejection
• Treatment with mofetil mycophenolate among cyclosporine or tacrolimus

Exclusion Criteria

• Transplant of any organ other than the kidney
• Current important infection
• Acute rejection within 12 weeks prior to inclusion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Renal function at 12 months; Comparison between slopes of glomerular filtration rate (GFR) of one year before versus one year after start on sirolimus

Secondary Outcome Measures

Name	Time	Method
Histological parameters at 12 months
Cumulative incidence of biopsy-confirmed acute rejection at 12 months
Effect at 12 months on proteinuria, blood pressure, hyperlipidemia, and proteinuria