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

Completed · Phase 4

Conditions studied: Graft Rejection, Kidney Failure

In brief

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.

Key facts

Study ID

NCT00369382

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

121

Starts

2006-09-01

Expected to finish

2010-05-01

Last updated by the study team

2011-05-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Rochester, Minnesota, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States
• Pfizer Investigational Site — Pittsburgh, Pennsylvania, United States
• Pfizer Investigational Site — Houston, Texas, United States
• Pfizer Investigational Site — Norfolk, Virginia, United States
• Pfizer Investigational Site — Darlinghurst, New South Wales, Australia
• Pfizer Investigational Site — Vienna, Austria
• Pfizer Investigational Site — Montreal, Quebec, Canada
• Pfizer Investigational Site — Québec, Quebec, Canada
• Pfizer Investigational Site — Sainte-Foy, Quebec, Canada
• Pfizer Investigational Site — Epsom, Auckland, New Zealand
• Pfizer Investigational Site — Auckland, New Zealand, New Zealand
• Pfizer Investigational Site — L'Hospitalet de Llobregat, Barcelona, Spain
• Pfizer Investigational Site — Santander, Cantabria, Spain
• Pfizer Investigational Site — La Coru?a, La Coru?a, Spain
• Pfizer Investigational Site — Madrid, Madrid, Spain
• Pfizer Investigational Site — Seville, Sevilla, Spain
• Pfizer Investigational Site — Valencia, Valencia, Spain
• Pfizer Investigational Site — Barcelona, Spain
• Pfizer Investigational Site — Bern, Switzerland

Full record on ClinicalTrials.gov

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