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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

May 27, 2009
April 15, 2010
April 2009
March 2010   (final data collection date for primary outcome measure)
Assessment of pharmacokinetic parameters [ Time Frame: Day 6 and Day 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00909571 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Liver Transplantation
  • Drug: FK506E (modified release tacrolimus)
    oral
    Other Name: MR4, modified release Tacrolimus
  • Drug: Prograf (tacrolimus)
    injection
    Other Names:
    • FK506
    • tacrolimus
  • Experimental: 1. FK506E high dose group
    Interventions:
    • Drug: FK506E (modified release tacrolimus)
    • Drug: Prograf (tacrolimus)
  • Experimental: 2. FK506E low dose group
    Interventions:
    • Drug: FK506E (modified release tacrolimus)
    • Drug: Prograf (tacrolimus)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00909571
MR-08-04-KOR
No
Director, Astellas Pharma, Inc
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Korea, Inc.
Astellas Pharma Inc
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP