Status:
COMPLETED
Pharmacokinetics of Tacrolimus in Liver Transplantation Patients Treated With Prograf and Modified Release Tacrolimus
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Korea, Inc.
Conditions:
Liver Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Tacrolimus pharmacokinetics study in primary living donor liver transplantation patients with Tacrolimus based immunosuppressive regimens.
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 livin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00909571
Start Date
April 1 2009
End Date
March 1 2010
Last Update
April 16 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul, South Korea