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 2 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 1-1.5g bid + tacrolimus + cyclosporine or Cellcept 1-1.5 g bid + sirolimus.The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Liver Transplantation	Drug: mycophenolate mofetil [CellCept] Drug: Tacrolimus Drug: Cyclosporine Drug: Sirolimus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Superiority for calculated GFR [ Time Frame: 12 months post-transplant ] [ Designated as safety issue: No ]
Non-inferiority of biopsy-proven acute rejection; graft survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Patient survival [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Acute rejection episode, biopsy-proven acute rejection, treatment for rejection, time to first acute rejection, incidence of treatment failure. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment:	294
Study Start Date:	August 2005

Arms	Assigned Interventions
1: Experimental	Drug: mycophenolate mofetil [CellCept] 1-1.5g po bid Drug: Sirolimus As prescribed
2: Active Comparator	Drug: mycophenolate mofetil [CellCept] 1-1.5g po bid Drug: Tacrolimus As prescribed Drug: Cyclosporine As prescribed

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

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Locations

United States, Alabama

BIRMINGHAM, Alabama, United States, 35294
United States, Arizona

PHOENIX, Arizona, United States, 85054
United States, California

LOS ANGELES, California, United States, 90095

SAN FRANCISCO, California, United States, 94143-0780

LOS ANGELES, California, United States, 90033-4612

SAN DIEGO, California, United States, 92103-8401

SAN FRANCISCO, California, United States, 94115

LA JOLLA, California, United States, 92037
United States, Colorado

DENVER, Colorado, United States, 80262
United States, Florida

TAMPA, Florida, United States, 33606

JACKSONVILLE, Florida, United States, 32216

MIAMI, Florida, United States, 33136
United States, Georgia

ATLANTA, Georgia, United States, 30322
United States, Illinois

CHICAGO, Illinois, United States, 60612-3824

CHICAGO, Illinois, United States, 60611
United States, Louisiana

NEW ORLEANS, Louisiana, United States, 70121
United States, Maryland

BALTIMORE, Maryland, United States, 21201
United States, Massachusetts

BURLINGTON, Massachusetts, United States, 01805

BOSTON, Massachusetts, United States, 02114-2696

BOSTON, Massachusetts, United States, 02215

BOSTON, Massachusetts, United States, 02111
United States, Michigan

DETROIT, Michigan, United States, 48202-2689
United States, Minnesota

ROCHESTER, Minnesota, United States, 55905

MINNEAPOLIS, Minnesota, United States, 55455
United States, Missouri

ST LOUIS, Missouri, United States, 63110
United States, New Jersey

NEWARK, New Jersey, United States, 07101-1709
United States, New York

NEW YORK, New York, United States, 10029

NEW YORK, New York, United States, 10016

NEW YORK, New York, United States, 10032

HAWTHORNE, New York, United States, 10532
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

SAN ANTONIO, Texas, United States, 78284

DALLAS, Texas, United States, 75246

HOUSTON, Texas, United States, 77030
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, H3A 1A1

MONTREAL, Quebec, Canada, H2X 3J4

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML18423
Study First Received:	June 30, 2005
Last Updated:	March 16, 2009
ClinicalTrials.gov Identifier:	NCT00118742 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Cyclosporine
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors
Tacrolimus

Antibiotics, Antineoplastic
Cyclosporins
Immunosuppressive Agents
Pharmacologic Actions
Anti-Bacterial Agents
Therapeutic Uses
Antifungal Agents
Mycophenolate mofetil
Antirheumatic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on November 30, 2009