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Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00118742
Recruitment Status : Completed
First Posted : July 12, 2005
Results First Posted : March 10, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine Drug: Sirolimus Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 293 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2005
Actual Primary Completion Date : July 2008
Actual Study Completion Date : December 2008


Arm Intervention/treatment
Experimental: CellCept + CNI (tacrolimus or cyclosporine) Drug: mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily

Drug: Tacrolimus
As prescribed, for 12 months

Drug: Cyclosporine
As prescribed, for 12 months

Active Comparator: CellCept + sirolimus Drug: mycophenolate mofetil [CellCept]
1-1.5 g orally or intravenously twice daily

Drug: Sirolimus
2-4 mg orally once daily for 9-11 months




Primary Outcome Measures :
  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 12 Months Posttransplant [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change From Baseline in Glomerular Filtration Rate (GFR) at 6 Months Posttransplant [ Time Frame: 6 months posttransplant ]
    Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

  2. Change From Baseline in Glomerular Filtration Rate (GFR) at 24 Months Posttransplant [ Time Frame: 24 months posttransplant ]
    Mean percent change from baseline in estimated GFR calculated by modification of diet in renal disease (MDRD)-6 variable equation at 6 and 24 months posttransplantation. MDRD-6 variables: serum creatinine, albumin and urea nitrogen, gender, age and ethnicity.

  3. Change From Baseline in Creatinine Clearance [ Time Frame: 6, 12, and 24 months posttransplantation ]
    Mean percent change from baseline in calculated creatinine clearance (CL) at 6, 12, and 24 months posttransplantation



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00118742


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35294
United States, Arizona
Phoenix, Arizona, United States, 85054
United States, California
La Jolla, California, United States, 92037
Los Angeles, California, United States, 90033-4612
Los Angeles, California, United States, 90095
San Diego, California, United States, 92103-8401
San Francisco, California, United States, 94115
San Francisco, California, United States, 94143-0780
United States, Colorado
Denver, Colorado, United States, 80262
United States, Florida
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33136
Tampa, Florida, United States, 33606
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Illinois
Chicago, Illinois, United States, 60611
Chicago, Illinois, United States, 60612-3824
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Boston, Massachusetts, United States, 02111
Boston, Massachusetts, United States, 02114-2696
Boston, Massachusetts, United States, 02215
Burlington, Massachusetts, United States, 01805
United States, Michigan
Detroit, Michigan, United States, 48202-2689
United States, Minnesota
Minneapolis, Minnesota, United States, 55455
Rochester, Minnesota, United States, 55905
United States, Missouri
St Louis, Missouri, United States, 63110
United States, New Jersey
Newark, New Jersey, United States, 07101-1709
United States, New York
Hawthorne, New York, United States, 10532
New York, New York, United States, 10016
New York, New York, United States, 10029
New York, New York, United States, 10032
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112-4481
United States, Oregon
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19141
United States, Tennessee
Nashville, Tennessee, United States, 37232
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78284
United States, Virginia
Richmond, Virginia, United States, 23298
United States, Wisconsin
Madison, Wisconsin, United States, 53792
Canada, Alberta
Edmonton, Alberta, Canada, T6G 2B7
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
London, Ontario, Canada, N6A 5A5
Canada, Quebec
Montreal, Quebec, Canada, H2X 3J4
Montreal, Quebec, Canada, H3A 1A1
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
Additional Information:
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Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00118742    
Other Study ID Numbers: ML18423
First Posted: July 12, 2005    Key Record Dates
Results First Posted: March 10, 2010
Last Update Posted: August 3, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Cyclosporine
Sirolimus
Mycophenolic Acid
Tacrolimus
Cyclosporins
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents