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

Sponsor:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00118742

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 IV

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:

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Sirolimus Cyclosporine Cyclosporin Tacrolimus anhydrous Tacrolimus Mycophenolate mofetil hydrochloride Mycophenolate Mofetil Everolimus CCI 779

U.S. FDA Resources

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:

Clinical Study Report Synopsis This link exits the ClinicalTrials.gov site

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
Sirolimus
Everolimus
Mycophenolate mofetil
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 February 12, 2012