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

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Korea, Inc.
• Treatments: Tacrolimus

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