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:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00118742
First received: June 30, 2005
Last updated: July 30, 2010
Last verified: July 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 74 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00118742

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

Additional Information:
No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00118742     History of Changes
Other Study ID Numbers: ML18423
Study First Received: June 30, 2005
Results First Received: May 13, 2009
Last Updated: July 30, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014