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

Liver Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00909571
• Other study ID #: MR-08-04-KOR
• Status: Completed
• Phase: Phase 3
• First received: May 27, 2009
• Last updated: April 15, 2010
• Start date: April 2009
• Est. completion date: March 2010

Study information

• Verified date: April 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• FK506E (modified release tacrolimus)
oral
• Prograf (tacrolimus)
injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of pharmacokinetic parameters		Day 6 and Day 14	No
Secondary	Incidence of acute rejection		within 12 weeks	No
Secondary	Time to acute rejection		within 12 weeks	No
Secondary	Assessment of graft survival		within 12 weeks	No