- Age greater than 13 years (age greater than 18 years as required by some local
- 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
- History of nonhepatic transplantation
- Evidence of systemic infection (sepsis, bacteremia, pneumonia etc).
- Known or suspected malignancy