RESCUE Study - Everolimus in Liver Transplantation Recipients With Renal Insufficiency

Inclusion criteria

• Male or female 18 - 70 years old
• Patient who has undergone a primary liver transplantation 12 to 60 months ago from a cadaveric or a living donor
• Patient with a calculated GFR ≤ 60 and ≥ 20mL/min
• Patient receiving tacrolimus with C0-h level ≥ 3 and ≤ 8 ng/mL or Neoral® with C0-h level ≥ 50 and ≤ 150 ng/mL or with C2-h level ≥ 250 ng/mL and ≤ 650 ng/mL with or without any of the following (MPA or AZA or steroids)
• Patient willing and capable of giving written informed consent for study participation and able to participate in the study for 6 months
• Patient in whom an allograft biopsy will not be contraindicated
• Female capable of becoming pregnant must have a negative pregnancy test prior to randomization and are required to practice a medically approved method of birth control for the duration of the study

Exclusion criteria

• Recipient of multiple solid organ transplants
• Patient on dialysis
• Patient with an identifiable cause of renal dysfunction other than CNI toxicity
• Patient with proteinuria ≥ 1.0 g/24h
• Patient with any acute rejection within 6 months prior to randomization
• Patient with platelet count of ≤ 50,000/mm³ or white blood cell count of ≤ 2,000/mm³ or hemoglobin value ≤ 8 g/dL
• Undergone a liver transplantation for a hepatocellular carcinoma with sign of recurrence;
• Severe graft dysfunction;
• HCV positive patient who needs an active anti-viral treatment
• HIV positive patient
• Patient who is breast feeding
• Patient with a current severe systemic infection
• Patient who has received an unlicensed drug or therapy within one month prior to study entry
• Presence of any hypersensitivity to drugs similar to everolimus (e.g. macrolides)
• Use of any other immunosuppressive drugs than tacrolimus/cyclosporine microemulsion, steroids, azathioprine and mycophenolic acid

Additional protocol-defined inclusion/exclusion criteria may apply.