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

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

MedlinePlus related topics:

Liver Transplantation

ChemIDplus related topics:

Tacrolimus Cyclosporine Cyclosporin Mycophenolate Mofetil Mycophenolate mofetil hydrochloride Sirolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, 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

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 43 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators


Study Director:	Clinical Trials	Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML18423
First Received:	June 30, 2005
Last Updated:	August 18, 2008
ClinicalTrials.gov Identifier:	NCT00118742
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Sirolimus

Cyclosporine

Clotrimazole

Miconazole

Tioconazole

Mycophenolic Acid

Mycophenolate mofetil

Tacrolimus

Cyclosporins

Additional relevant MeSH terms:

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antibiotics, Antineoplastic

Immunosuppressive Agents

Pharmacologic Actions

Anti-Bacterial Agents

Antifungal Agents

Therapeutic Uses

Antirheumatic Agents

Dermatologic Agents

ClinicalTrials.gov processed this record on September 04, 2008

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