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Completed

NCT Number: NCT00909571

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

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

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Key information

Conditions

Liver Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FK506E (modified release tacrolimus)

Drug

oral

Other names: MR4, modified release Tacrolimus

Prograf (tacrolimus)

Drug

injection

Other names: FK506, tacrolimus

Primary outcomes

  1. Assessment of pharmacokinetic parameters

    Time frame: Day 6 and Day 14

Secondary outcomes

  1. Incidence of acute rejection

    Time frame: within 12 weeks

  2. Time to acute rejection

    Time frame: within 12 weeks

  3. Assessment of graft survival

    Time frame: within 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Korea, Inc.

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
May 28, 2009
Registry last updated
Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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