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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Everolimus (RAD001) with MMF and Steroids
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids
Renal Function
The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.
Time frame: Randomization to Month 6
Efficacy (tBPAR, graft loss, death, loss to follow-up)
Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date.
Time frame: To Month 6
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