Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Phase 3
Completed
- Conditions
- Liver Transplantation
- Interventions
- Drug: FK506E (modified release tacrolimus)
- Registration Number
- NCT00909571
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2. FK506E low dose group FK506E (modified release tacrolimus) - 1. FK506E high dose group FK506E (modified release tacrolimus) - 1. FK506E high dose group Prograf (tacrolimus) - 2. FK506E low dose group Prograf (tacrolimus) -
- Primary Outcome Measures
Name Time Method Assessment of pharmacokinetic parameters Day 6 and Day 14
- Secondary Outcome Measures
Name Time Method Incidence of acute rejection within 12 weeks Time to acute rejection within 12 weeks Assessment of graft survival within 12 weeks