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

This study has been completed.
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc Identifier:
First received: May 27, 2009
Last updated: April 15, 2010
Last verified: April 2010
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.

Condition Intervention Phase
Liver Transplantation
Drug: FK506E (modified release tacrolimus)
Drug: Prograf (tacrolimus)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official 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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Assessment of pharmacokinetic parameters [ Time Frame: Day 6 and Day 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of acute rejection [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]
  • Time to acute rejection [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]
  • Assessment of graft survival [ Time Frame: within 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1. FK506E high dose group Drug: FK506E (modified release tacrolimus)
Other Name: MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
Other Names:
  • FK506
  • tacrolimus
Experimental: 2. FK506E low dose group Drug: FK506E (modified release tacrolimus)
Other Name: MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
Other Names:
  • FK506
  • tacrolimus

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00909571

Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Korea, Inc.
  More Information

Responsible Party: Director, Astellas Pharma, Inc Identifier: NCT00909571     History of Changes
Other Study ID Numbers: MR-08-04-KOR 
Study First Received: May 27, 2009
Last Updated: April 15, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Living Liver Transplantation

Additional relevant MeSH terms:
Calcineurin Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016