Endpoints
The primary endpoint of this study was the incidence of liver
dysfunction that required discontinuation or dosage modification of
tacrolimus from registration to six months. The liver dysfunction was
defined as an AST or ALT level greater than two times the upper limit of
normal. The secondary endpoints were tacrolimus trough level changes and
the incidence of acute rejection. The rejection was defined according to
the Banff criteria for liver biopsy 12,13.
Additionally, the changes in pharmacokinetic parameters of tacrolimus
before and after the conversion to once-daily extended-release
formulation were analyzed.