LIVER TRANSPLANTATION Clinical Trial
Official title:
AN OPEN, MULTICENTRE, RANDOMISED PARALLEL GROUP CLINICAL STUDY TO COMPARE SAFETY AND EFFICACY OF TACROLIMUS (FK506) WITH MONOCLONAL ANTI-IL2R ANTIBODIES (DACLIZUMAB) VS TACROLIMUS (FK506) WITH STEROIDS AND EVALUATE PHARMACOKINETICS IN LIVER ALLOGRAFT RECIPIENTS RECEIVING SUBOPTIMAL LIVERS
The purpose of the study is to compare the safety and efficacy of two different tacrolimus
based immunosuppressive regimens, one in combination with daclizumab, the other in
combination with steroids, in recipients of suboptimal livers.
Pharmacokinetics of tacrolimus and bile composition will be measured in a subgroup of
patients.
Open, multicentre, 1:1 randomised, parallel group phase III study to compare safety and
efficacy of tacrolimus (FK506) with monoclonal anti-IL2R antibodies (daclizumab) vs
tacrolimus (FK506) with steroids and evaluate pharmacokinetics in liver allograft recipients
receiving suboptimal livers.
Patients receiving primary suboptimal liver allograft transplantation (from donors > 65
years and/or liver macrosteatosis >15%) will be randomised to one of the following treatment
arms:
Group I: steroid bolus (intraoperative) monoclonal anti-IL2R antibodies (daclizumab)
induction tacrolimus Group II: steroid bolus (intraoperative) tacrolimus steroids
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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