Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
NCT ID: NCT00909571
Last Updated: 2010-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
10 participants
INTERVENTIONAL
2009-04-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1. FK506E high dose group
FK506E (modified release tacrolimus)
oral
Prograf (tacrolimus)
injection
2. FK506E low dose group
FK506E (modified release tacrolimus)
oral
Prograf (tacrolimus)
injection
Interventions
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FK506E (modified release tacrolimus)
oral
Prograf (tacrolimus)
injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 an auxiliary graft or in whom a bio-artificial liver has been used
* Patients allergic or intolerant to macrolide antibodies or Tacrolimus
18 Years
ALL
No
Sponsors
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Astellas Pharma Korea, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Astellas Pharma, Inc
Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Korea, Inc.
Locations
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Seoul, , South Korea
Countries
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Other Identifiers
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MR-08-04-KOR
Identifier Type: -
Identifier Source: org_study_id
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