Purpose:
The purpose of this study is to evaluate the sirolimus conversion regimen as compared with
the calcineurin inhibitor continuation regimen with regards to renal function in stable
liver transplant subjects.
Criteria:
Inclusion Criteria:
- Age greater than 13 years (age greater than 18 years as required by some local
regulations).
- Receiving immunosuppressive therapy with calcineurin inhibitors (CI) +/-
corticosteroids +/- antimetabolite.
- 6 to 144 months after orthotopic liver transplantation.
- Cockcroft-Gault GFR values ≥40 mL/min and ≤90mL/min at screening
Exclusion Criteria:
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy < 5 years before random assignment.