Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
NCT ID: NCT00121810
Last Updated: 2011-04-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
305 participants
INTERVENTIONAL
2003-08-31
2009-11-30
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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1
mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Corticosteroids
As prescribed
Sirolimus
As prescribed
2
mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Corticosteroids
As prescribed
Calcineurin inhibitors
As prescribed
Interventions
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mycophenolate mofetil [CellCept]
1.0-1.5 g oral dose twice daily
Corticosteroids
As prescribed
Calcineurin inhibitors
As prescribed
Sirolimus
As prescribed
Eligibility Criteria
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Inclusion Criteria
* Kidney transplant 30-180 days post-transplantation
* Receipt of cyclosporine or tacrolimus, CellCept, and corticosteroids for greater than 14 days prior to study entry
* No known contraindications to sirolimus
Exclusion Criteria
* Corticosteroid-resistant rejection episode within 90 days prior to study entry or corticosteroid-sensitive rejection episode within 30 days prior to study entry
* More than 1 biopsy-proven episode of acute rejection prior to study entry
* Treated with sirolimus before the study
* Organ transplant or expected organ transplant, other than kidney
* History of malignancy in the last 5 years (except successfully treated localized non-melanotic skin cancer)
18 Years
75 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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Bakersfield, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Riverside, California, United States
San Diego, California, United States
San Francisco, California, United States
Denver, Colorado, United States
Hartford, Connecticut, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Camden, New Jersey, United States
Livingston, New Jersey, United States
New York, New York, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Memphis, Tennessee, United States
Nashville, Tennessee, United States
Dallas, Texas, United States
Galveston, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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ML17140
Identifier Type: -
Identifier Source: org_study_id
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