Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus

A Phase 3 Pilot Study to Describe the Pharmacokinetics of Tacrolimus in Patients Undergoing Primary Liver Donor Liver Transplantation Treated With Prograf Injection and Modified Release Tacrolimus Based Immunosuppressive Regimen

Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

To describe the pharmacokinetics of Tacrolimus when administered as two different doses of modified release formulation FK506E(MR4) combined with Prograf injection in patients undergoing primary living donor liver transplantation based on the single center (Asan Medical Center) standard protocol regimen.

Inclusion Criteria:

• Patients receiving a primary partial liver graft from a living donor
• Patients must receive the first dose of Tacrolimus after surgery and are expected to be maintained on Tacrolimus throughout the study

Exclusion Criteria:

• Patients receiving a multi-organ transplantation or having previously received an organ transplantation
• Patients receiving an auxiliary graft or in whom a bio-artificial liver has been used
• Patients allergic or intolerant to macrolide antibodies or Tacrolimus