Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Transplantation
Intervention: FK506E (modified release tacrolimus) (Drug); Prograf (tacrolimus) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Use Central Contact, Study Chair, Affiliation: Astellas Pharma Korea, Inc.
Summary
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients
with Tacrolimus based immunosuppressive regimens.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label
Primary outcome: Assessment of pharmacokinetic parameters
Secondary outcome: Incidence of acute rejectionTime to acute rejection Assessment of graft survival
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Seoul, Korea, Republic of
Additional Information
Starting date: April 2009
Last updated: April 15, 2010
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