Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients

Phase 3

Terminated

• Conditions: Kidney Transplant

• Registration Number: NCT00137345
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-29
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2006-09
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Dialysis patients who will be receiving their first kidney transplant
• Weight over 88 pounds (lbs.)

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Exclusion Criteria

• Very high cholesterol levels
• Obesity
• Organ donor over 65 years of age if living; over 60 years of age if cadaveric.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To demonstrate the superiority of the sirolimus regimen versus cyclosporin A by intent to treat analysis of kidney function at 52 weeks, measured by mean glomerular filtration rate (GFR)
Non-inferiority of the composite of graft loss and death at 52 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence and severity of rejection at 12, 24, 52, 104, 156, 208 weeks; GFR at 24, 104, 156, 208 weeks; progression of chronic allograft nephropathy or deterioration of transplanted kidney at 52 weeks
quality of life at 24, 52 and 104 weeks