• 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 ]

• 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 ]

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.

• Drug: mycophenolate mofetil [CellCept]
• Drug: Tacrolimus
• Drug: Cyclosporine
• Drug: Sirolimus

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.