Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
NCT ID: NCT00118742
Last Updated: 2010-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
293 participants
INTERVENTIONAL
2005-08-31
2008-12-31
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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CellCept + CNI (tacrolimus or cyclosporine)
mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
Tacrolimus
As prescribed, for 12 months
Cyclosporine
As prescribed, for 12 months
CellCept + sirolimus
mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
Sirolimus
2-4 mg orally once daily for 9-11 months
Interventions
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mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily
Tacrolimus
As prescribed, for 12 months
Cyclosporine
As prescribed, for 12 months
Sirolimus
2-4 mg orally once daily for 9-11 months
Eligibility Criteria
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Inclusion Criteria
* Single primary liver transplant from a deceased donor
* CellCept plus tacrolimus or cyclosporine from time of transplantation (within 72 hours)
* Patients with hepatitis C-positive status may be entered if they have had an intraoperative (back table) biopsy of the transplanted liver or will have a biopsy at the time of randomization. This is not required for patients negative for hepatitis C.
Exclusion Criteria
* Multiple organ transplant
* Dialysis therapy for \>14 days from transplantation to randomization
* History of malignancy in the last 5 years (except hepatoma or non-melanoma skin cancer)
* Previous sirolimus therapy
18 Years
74 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Hoffmann-La Roche
Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
San Diego, California, United States
San Francisco, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Burlington, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Newark, New Jersey, United States
Hawthorne, New York, United States
New York, New York, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Cleveland, Ohio, United States
Oklahoma City, Oklahoma, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Countries
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Other Identifiers
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ML18423
Identifier Type: -
Identifier Source: org_study_id
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