A MULTICENTER, THREE ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY TO COMPARE RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT A MONOCLONAL ANTI-IL2R ANTIBODY (BASILIXIMAB)

INTERVENTION:

Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5‐ Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1.0‐ Trade Name: Advagraf Pharmaceutical Form: Capsule, hard INN or Proposed

INN:

TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.0‐ Trade Name: Simulect Pharmaceutical Form: Powder and solvent for solution for injection Other descriptive name: BASILIXIMAB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20‐

CONDITION:

RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST‐TRANSPLANT) AND MMF WITH OR WITHOUT SIMULECT ; MedDRA version: 9.1 Level: LLT Classification code 10024716 Term: Liver transplantation

PRIMARY OUTCOME:

Main Objective: The primary objective of this study is to compare the three therapy regimens with regard to renal function. Primary end point(s): Renal function assessed by eGFR (MDRD4 formula: estimates GFR using four variables: serum creatinine, age, race, and gender) at 24 weeks after transplantation is the primary endpoint of the study. Secondary Objective: The secondary objective is to compare the safety and efficacy profiles of the three therapy regimens with each other.

INCLUSION CRITERIA:

A subject is eligible for the study if all of the following apply: 1. Age = 18 years. 2. Undergoing orthotopic liver or split liver allograft transplantation. 3. Female subject of childbearing potential must have a negative serum or urine pregnancy test at enrollment and must agree to maintain effective birth control during the study and during 6 weeks after cellcept is stopped 4. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed Informed Consent has been obtained). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range