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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00909571
First Posted: May 28, 2009
Last Update Posted: April 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc
  Purpose
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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • 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 ]

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)
oral
Other Name: MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
injection
Other Names:
  • FK506
  • tacrolimus
Experimental: 2. FK506E low dose group Drug: FK506E (modified release tacrolimus)
oral
Other Name: MR4, modified release Tacrolimus
Drug: Prograf (tacrolimus)
injection
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909571


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

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00909571     History of Changes
Other Study ID Numbers: MR-08-04-KOR
First Submitted: May 27, 2009
First Posted: May 28, 2009
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by Astellas Pharma Inc:
FK506E
MR4
Prograf
Tacrolimus
Living Liver Transplantation

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action