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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00909571
First received: May 27, 2009
Last updated: April 15, 2010
Last verified: April 2010
History of Changes
  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
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:

Drug Information available for: Tacrolimus
U.S. FDA Resources

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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov 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:
FK506E
MR4
Prograf
Tacrolimus
Living Liver Transplantation

Additional relevant MeSH terms:
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013