Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
NCT ID: NCT00086346
Last Updated: 2010-04-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
607 participants
INTERVENTIONAL
2002-12-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Sirolimus (Rapamune)
B
Cyclosporine or Tacrolimus
Interventions
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Sirolimus (Rapamune)
Cyclosporine or Tacrolimus
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
* Known or suspected malignancy \< 5 years before random assignment.
13 Years
ALL
No
Sponsors
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Wyeth is now a wholly owned subsidiary of Pfizer
INDUSTRY
Responsible Party
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Wyeth
Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Wyeth is now a wholly owned subsidiary of Pfizer
Locations
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San Francisco, California, United States
Tampa, Florida, United States
New Orleans, Louisiana, United States
Detroit, Michigan, United States
Rochester, Minnesota, United States
Omaha, Nebraska, United States
New York, New York, United States
Rochester, New York, United States
Cleveland, Ohio, United States
Philadelphia, Pennsylvania, United States
Ghent, , Belgium
Edmonton, Alberta, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Prague, , Czechia
Clichy, , France
Lyon, , France
Nice, , France
Paris, , France
Rennes, , France
Villejuif, , France
Berlin, , Germany
Hamburg, , Germany
München, , Germany
Bologna, , Italy
Milan, , Italy
Padua, , Italy
Leiden, , Netherlands
Coimbra, , Portugal
Lisbon, , Portugal
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Pamplona, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Bern, , Switzerland
Zurich, , Switzerland
Birmingham, , United Kingdom
Edinburgh, , United Kingdom
Leeds, , United Kingdom
Countries
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Other Identifiers
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0468H1-313
Identifier Type: -
Identifier Source: org_study_id
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