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

Study Overview
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Brief Summary
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Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

Detailed Description
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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.

Official Title
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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

Conditions
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Liver Transplantation

Intervention / Treatment
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* Drug: FK506E (modified release tacrolimus)
* Drug: Prograf (tacrolimus)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. FK506E high dose group<br> | Drug: FK506E (modified release tacrolimus)<br>* oral<br>* Other names: MR4, modified release Tacrolimus;Drug: Prograf (tacrolimus)<br>* injection<br>* Other names: tacrolimus;|
| Experimental: 2. FK506E low dose group<br> | Drug: FK506E (modified release tacrolimus)<br>* oral<br>* Other names: MR4, modified release Tacrolimus;Drug: Prograf (tacrolimus)<br>* injection<br>* Other names: tacrolimus;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pharmacokinetic parameters |  | Day 6 and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of acute rejection |  | within 12 weeks | 
| Time to acute rejection |  | within 12 weeks | 
| Assessment of graft survival |  | within 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FK506E, MR4, Prograf, Tacrolimus, Living Liver Transplantation