CompletedPhase 4

Study Of The Safety And Efficacy Of Conversion From A CNI To Sirolimus In Renally-Impaired Heart Transplant Recipients

United States121 participantsStarted 2006-09

Plain-language summary

The primary purpose of this study is to determine whether converting from calcineurin inhibitor (CNI) therapy to sirolimus therapy will be more effective than continuing calcineurin inhibitor therapy with respect to renal function in cardiac transplant recipients with mild to moderate renal dysfunction.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Cardiac transplant recipients age 18 years or older receiving cyclosporine or tacrolimus since the time of transplant. * 12 months after cardiac transplantation but less than 96 months post-transplantation. Exclusion Criteria: * Multiple-organ transplant recipients (such as heart-lung, heart-kidney, or heart after kidney transplant recipients). * Prior or current use of sirolimus or everolimus unless administration was part of a "CNI holiday" lasting no more than 10 days. * History of acute rejection within the last 3 months, malignancy within the last 5 years (except for adequately treated basal cell or squamous cell carcinoma of the skin), and human immunodeficiency virus (HIV) patients.

What they're measuring

Change From Baseline in Calculated Creatinine Clearance (Cockcroft-Gault Equation) at 52 Weeks Post-randomization

Timeframe: Baseline and Week 52

Calculated Creatinine Clearance (Cockcroft-Gault Equation) at Baseline

Timeframe: Baseline

Trial details

NCT IDNCT00369382

SponsorWyeth is now a wholly owned subsidiary of Pfizer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-04

Results submitted2011-04-26

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