Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients

Phase 4

Completed

• Conditions: Aged; Kidney Failure; Graft Rejection

• Registration Number: NCT00254709
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study Completion: 2005-09
• Study First Submitted: 2005-11-11
• Study First Submitted QC: 2005-11-14
• Study First Posted: 2005-11-16
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-26
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• End stage renal disease
• Kidney transplantation
• Both donor and recipient older than 60 years

Exclusion Criteria

• Prior or concurrent transplant of any organ other than the kidney
• Current clinically significant infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Renal function at 3 and 12 months; measured by Cockroft-Gault formula or serum creatinine

Secondary Outcome Measures

Name	Time	Method
Time to recover renal function (creatinine< 2 mg/dl)
Incidence of acute rejections at 3 and 12 months
Patient and graft survival at 3 and 12 months
Incidence and duration of episodes of acute tubular necrosis