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.