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

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: Prograf (tacrolimus); Drug: FK506E (modified release tacrolimus)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909571

MR-08-04-KOR

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 2 patient groups

1. FK506E high dose group

Experimental group

Treatment:

Drug: FK506E (modified release tacrolimus)

Drug: Prograf (tacrolimus)

2. FK506E low dose group

Experimental group

Treatment:

Drug: FK506E (modified release tacrolimus)

Drug: Prograf (tacrolimus)