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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 rejection

Time 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

Page last updated: August 23, 2015

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