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

Astellas Pharma Inc10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Liver Transplantation

Interventions

FK506E (modified release tacrolimus)DRUG

oral

Prograf (tacrolimus)DRUG

injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Seoul, South Korea

Outcomes

Primary Outcomes

Assessment of pharmacokinetic parameters

Time frame: Day 6 and Day 14

Secondary Outcomes

Incidence of acute rejection

Time frame: within 12 weeks

Time to acute rejection

Time frame: within 12 weeks

Assessment of graft survival

Time frame: within 12 weeks

Data from ClinicalTrials.gov

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