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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00118742
First Posted: July 12, 2005
Last Update Posted: August 3, 2010
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.
Information provided by:
Hoffmann-La Roche
  Purpose
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 Intervention Phase
Liver Transplantation Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine Drug: Sirolimus Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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


Enrollment: 293
Study Start Date: August 2005
Study Completion Date: December 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
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
  Contacts and Locations
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


  Show 46 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Additional Information:
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00118742     History of Changes
Other Study ID Numbers: ML18423
First Submitted: June 30, 2005
First Posted: July 12, 2005
Results First Submitted: May 13, 2009
Results First Posted: March 10, 2010
Last Update Posted: August 3, 2010
Last Verified: July 2010

Additional relevant MeSH terms:
Tacrolimus
Cyclosporins
Cyclosporine
Sirolimus
Everolimus
Calcineurin Inhibitors
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Anti-Bacterial Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents