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

Roche

Status and phase

Completed

Phase 4

Conditions

Liver Transplantation

Treatments

Drug: mycophenolate mofetil [CellCept]

Drug: Tacrolimus

Drug: Cyclosporine

Drug: Sirolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT00118742

ML18423

Details and patient eligibility

About

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.

Enrollment

293 patients

Sex

All

Ages

18 to 74 years old

Volunteers

No Healthy Volunteers

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