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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00909571

Enrollment

Registered

2009-05-28

Start date

2009-04-30

Completion date

2010-03-31

Last updated

2010-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

FK506E, MR4, Prograf, Tacrolimus, Living Liver Transplantation

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.

Interventions

DRUGFK506E (modified release tacrolimus)

oral

DRUGPrograf (tacrolimus)

injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Assessment of pharmacokinetic parameters	Day 6 and Day 14

Secondary

Measure	Time frame
Incidence of acute rejection	within 12 weeks
Time to acute rejection	within 12 weeks
Assessment of graft survival	within 12 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026