Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)

Inclusion Criteria:

• Patients willing and capable of providing written informed consent for study participation.
• Adults 18 to 70 years of age.
• Liver allograft from a deceased or living donor.
• Treated with a CNI containing immunosuppressive regimen.
• Liver transplant 6 to 24 months prior to screening.
• Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min < eGFR < CKD II/60 mL/min with deteriorating renal function.
• Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion Criteria:

• Multiple solid organ transplant recipients
• Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis
• Malignant diseases other than neoplasms of the skin.
• Patient on other investigational drug or presence of any hypersensitivity to the interventional drug.
• Pregnant or nursing (lactating) women.
• Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception).
• Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria
• HIV positivity

Other protocol-defined inclusion/exclusion criteria may apply.