Overview

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

Status:
Completed

Trial end date:
2008-12-01

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 4

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Calcineurin Inhibitors
Cyclosporine
Cyclosporins
Everolimus
Mycophenolate mofetil
Mycophenolic Acid
Sirolimus
Tacrolimus