Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients
NCT00086346
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy < 5 years before random assignment.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Seoul, Agree
- San Francisco, California
- Tampa, Florida
- New Orleans, Louisiana
- Detroit, Michigan
- Rochester, Minnesota
- Omaha, Nebraska
- New York, New York
- Rochester, New York
- Cleveland, Ohio
- Philadelphia, Pennsylvania
- Gent,
- Edmonton, Alberta
- London, Ontario
- Toronto, Ontario
- Prague,
- Clichy,
- Lyon,
- Nice,
- Paris,
- Rennes,
- Villejuif,
- Berlin,
- Hamburg,
- München,
- Bologna,
- Milano,
- Padova,
- Leiden,
- Coimbra,
- Lisboa,
- Barcelona,
- Barcelona,
- Barcelona,
- Madrid,
- Pamplona,
- Santiago de Compostela,
- Valencia,
- Bern,
- Zürich,
- Birmingham,
- Edinburgh,
- Leeds,
Descriptive Information | |||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Brief Title ICMJE | Study Evaluating of Calcineurin Inhibitor and Sirolimus (Rapamune) Treatment in Liver Transplant Recipients | ||||||||||||||||||||||||
Official Title ICMJE | A Randomized, Open-Label, Comparative Evaluation of Conversion From Calcineurin Inhibitor Treatment to Sirolimus Treatment Versus Continued Calcineurin Inhibitor Treatment in Liver Allograft Recipients Undergoing Maintenance Therapy | ||||||||||||||||||||||||
Brief Summary | 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. | ||||||||||||||||||||||||
Detailed Description | Not Provided | ||||||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||||||
Study Phase ICMJE | Phase 3 | ||||||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||||||||||||||||||||
Condition ICMJE | Liver Transplantation | ||||||||||||||||||||||||
Intervention ICMJE |
| ||||||||||||||||||||||||
Study Arms ICMJE |
| ||||||||||||||||||||||||
Publications * | Not Provided | ||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||||||||||||||||||||
Recruitment Information | |||||||||||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||||||||||
Actual Enrollment ICMJE | 607 | ||||||||||||||||||||||||
Original Enrollment ICMJE | Not Provided | ||||||||||||||||||||||||
Actual Study Completion Date ICMJE | July 2008 | ||||||||||||||||||||||||
Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | ||||||||||||||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||||||||||||||||||
Sex/Gender ICMJE |
| ||||||||||||||||||||||||
Ages ICMJE | 13 Years and older (Child, Adult, Older Adult) | ||||||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||
Listed Location Countries ICMJE | Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, United Kingdom, United States | ||||||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||
NCT Number ICMJE | NCT00086346 | ||||||||||||||||||||||||
Other Study ID Numbers ICMJE | 0468H1-313 | ||||||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||||||||||||||||||
IPD Sharing Statement ICMJE | Not Provided | ||||||||||||||||||||||||
Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||||||||||||||||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||||||
Investigators ICMJE |
| ||||||||||||||||||||||||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | ||||||||||||||||||||||||
Verification Date | April 2010 | ||||||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |