Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
A Randomized, Open-label Study of the Effect of a Long-term Calcineurin Inhibitor-free Maintenance Regimen With CellCept and Sirolimus on Preservation of Renal Function and Prevention of Acute Rejection in Recipients of an Orthotropic Liver Transplant
1 other identifier
interventional
293
2 countries
46
Brief Summary
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant. Patients will be randomized to receive either CellCept 1-1.5 g twice daily (BID) + tacrolimus + cyclosporine, or CellCept 1-1.5 g BID + sirolimus. The anticipated time on study treatment is 1 to 2 years, and the target sample size is 100 to 500 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2005
Typical duration for phase_4
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2005
CompletedFirst Posted
Study publicly available on registry
July 12, 2005
CompletedStudy Start
First participant enrolled
August 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 10, 2010
CompletedAugust 3, 2010
July 1, 2010
2.9 years
June 30, 2005
May 13, 2009
July 30, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant
Mean percent change from baseline in estimated glomerular filtration rate (GFR) calculated by modification of diet in renal disease (MDRD)-6 variable equation at 12 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.
12 months posttransplant
Secondary Outcomes (3)
Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant
6 months posttransplant
Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant
24 months posttransplant
Change From Baseline in Creatinine Clearance
6, 12, and 24 months posttransplantation
Study Arms (2)
CellCept + CNI (tacrolimus or cyclosporine)
EXPERIMENTALCellCept + sirolimus
ACTIVE COMPARATORInterventions
1-1.5 g orally or intravenously twice daily
Eligibility Criteria
You may qualify if:
- Adult patients 18-74 years of age
- 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.
You may not qualify if:
- Liver allograft from a living donor or a split liver
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Phoenix, Arizona, 85054, United States
Unknown Facility
La Jolla, California, 92037, United States
Unknown Facility
Los Angeles, California, 90033-4612, United States
Unknown Facility
Los Angeles, California, 90095, United States
Unknown Facility
San Diego, California, 92103-8401, United States
Unknown Facility
San Francisco, California, 94115, United States
Unknown Facility
San Francisco, California, 94143-0780, United States
Unknown Facility
Denver, Colorado, 80262, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33136, United States
Unknown Facility
Tampa, Florida, 33606, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60612-3824, United States
Unknown Facility
New Orleans, Louisiana, 70121, United States
Unknown Facility
Baltimore, Maryland, 21201, United States
Unknown Facility
Boston, Massachusetts, 02111, United States
Unknown Facility
Boston, Massachusetts, 02114-2696, United States
Unknown Facility
Boston, Massachusetts, 02215, United States
Unknown Facility
Burlington, Massachusetts, 01805, United States
Unknown Facility
Detroit, Michigan, 48202-2689, United States
Unknown Facility
Minneapolis, Minnesota, 55455, United States
Unknown Facility
Rochester, Minnesota, 55905, United States
Unknown Facility
St Louis, Missouri, 63110, United States
Unknown Facility
Newark, New Jersey, 07101-1709, United States
Unknown Facility
Hawthorne, New York, 10532, United States
Unknown Facility
New York, New York, 10016, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
New York, New York, 10032, United States
Unknown Facility
Chapel Hill, North Carolina, 27599, United States
Unknown Facility
Cleveland, Ohio, 44195, United States
Unknown Facility
Oklahoma City, Oklahoma, 73112-4481, United States
Unknown Facility
Portland, Oregon, 97201-3098, United States
Unknown Facility
Philadelphia, Pennsylvania, 19141, United States
Unknown Facility
Nashville, Tennessee, 37232, United States
Unknown Facility
Dallas, Texas, 75246, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
San Antonio, Texas, 78284, United States
Unknown Facility
Richmond, Virginia, 23298, United States
Unknown Facility
Madison, Wisconsin, 53792, United States
Unknown Facility
Edmonton, Alberta, T6G 2B7, Canada
Unknown Facility
Halifax, Nova Scotia, B3H 3A7, Canada
Unknown Facility
London, Ontario, N6A 5A5, Canada
Unknown Facility
Montreal, Quebec, H2X 3J4, Canada
Unknown Facility
Montreal, Quebec, H3A 1A1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
There were no overall limitations and caveats.
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 30, 2005
First Posted
July 12, 2005
Study Start
August 1, 2005
Primary Completion
July 1, 2008
Study Completion
December 1, 2008
Last Updated
August 3, 2010
Results First Posted
March 10, 2010
Record last verified: 2010-07