Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
Tacrolimus and Daclizumab Versus Tacrolimus and Steroids in Liver Recipients Receiving Sub-optimal Grafts
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
Inclusion Criteria:

 -  Signed informed consent

 -  Adult patients scheduled to receive a liver transplant

 -  Donors older than 65 and/or has liver macrosteatosis >15%

 -  Female patients of childbearing potential agree to maintain effective birth control
 during the study and must have negative pregnancy test at baseline

 Exclusion Criteria:

 -  Patient has previously received or is receiving an organ transplant other than liver,
 or a liver re-transplantation.

 -  Patient has significant, uncontrolled concomitant infections and/or severe diarrhea,
 vomiting, or active peptic ulcer

 -  Patient is receiving an auxiliary graft or a bio-artificial liver has been used.

 -  Any pathology or medical condition that can interfere with this protocol study
 proposal

 -  Other exclusion applies