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

Show 46 Study Locations

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 09, 2009