Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients

Stopped early · Phase 3

Conditions studied: Liver Transplantation

In brief

The purpose of this study is to evaluate the sirolimus conversion regimen as compared with the calcineurin inhibitor continuation regimen with regards to renal function in stable liver transplant subjects.

Key facts

Study ID

NCT00086346

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

607

Starts

2002-12-01

Expected to finish

2008-07-01

Last updated by the study team

2010-04-28

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 13 years (age greater than 18 years as required by some local regulations).
• Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/- corticosteroids +/- antimetabolite.
• 6 to 144 months after orthotopic liver transplantation.
• Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening

You may not qualify if…

• History of nonhepatic transplantation
• Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
• Known or suspected malignancy < 5 years before random assignment.

Where it is running

• Study site — San Francisco, California, United States
• Study site — Tampa, Florida, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Detroit, Michigan, United States
• Study site — Rochester, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Ghent, Belgium
• Study site — Edmonton, Alberta, Canada
• Study site — London, Ontario, Canada
• Study site — Toronto, Ontario, Canada
• Study site — Prague, Czechia
• Study site — Clichy, France
• Study site — Lyon, France
• Study site — Nice, France
• Study site — Paris, France
• Study site — Rennes, France
• Study site — Villejuif, France
• Study site — Berlin, Germany
• Study site — Hamburg, Germany
• Study site — München, Germany
• Study site — Bologna, Italy

Full record on ClinicalTrials.gov

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