Conversion from cyclosporine to tacrolimus followed by randomized C0 or Bayesian monitoring using the C4 timepoint The effect on kidney function

INTERVENTION: Trade Name: Prograf(t) Product Name: Prograft Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Current Sponsor code: FK506 Other descriptive name: Prograf(t) Concentration unit: µg/l microgram(s)/litre Concentration type: range Concentration number: 4‐8 CONDITION: Effect of immunosuppressive medication on renal function following livertransplantation ; MedDRA version: 9.1 Level: LLT Classification code 10024716 Term: Liver transplantation PRIMARY OUTCOME: Main Objective: Change in cratinine clearance measured by creatinine clearence in 24 hours urine collection and serum creatinine between baseline and week 12, week 12 and 14, and baseline and week 24 Primary end point(s): Change in renal function, as measured by:; Creatinine clearance, measured by creatinine clearance in a 24 hour urine collection and serum creatinine between: 1) baseline and week 12, 2) week 12 and week 24 and 3) baseline and week 24 ; Creatinine clearance calculated by BSA adjusted Cockcroft and Gault and MDRD Secondary Objective: ‐ Changes in mean arterial blood pressure and number and dose of antihypertensive medications used between baseline and week 12 and baseline and week 24; ; ‐ Tacrolimus pharmacokinetics; ; ‐ Changes in mean lipid levels (total cholesterol, TG, LDL, HDL), and the number and ; dose of lipid‐lowering medications between baseline and week 12 and week 24; ; ‐ Subject and graft survival; ; ‐ Creatinine clearance calculated by BSA corrected Cockcroft and GAult and MDRD; ; ‐ Biopsy proven treated graft rejection; ; ‐ Side effects INCLUSION CRITERIA: Livertransplant recipients at least 18 years of age at least 6 months past last transplantation on a stable calcineurin inhibitor based immunosuppressive regimen capable of understanding the purpose and risk of the study. 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