NCT00909571

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

April 16, 2010

Status Verified

April 1, 2010

Enrollment Period

11 months

First QC Date

May 27, 2009

Last Update Submit

April 15, 2010

Conditions

Liver Transplantation

Keywords

FK506EMR4PrografTacrolimusLiving Liver Transplantation

Outcome Measures

Primary Outcomes (1)

  • Assessment of pharmacokinetic parameters

    Day 6 and Day 14

Secondary Outcomes (3)

  • Incidence of acute rejection

    within 12 weeks

  • Time to acute rejection

    within 12 weeks

  • Assessment of graft survival

    within 12 weeks

Study Arms (2)

1. FK506E high dose group

EXPERIMENTAL
Drug: FK506E (modified release tacrolimus)Drug: Prograf (tacrolimus)

2. FK506E low dose group

EXPERIMENTAL
Drug: FK506E (modified release tacrolimus)Drug: Prograf (tacrolimus)

Interventions

FK506E (modified release tacrolimus)DRUG

oral

Also known as: MR4, modified release Tacrolimus
1. FK506E high dose group2. FK506E low dose group
Prograf (tacrolimus)DRUG

injection

Also known as: FK506, tacrolimus
1. FK506E high dose group2. FK506E low dose group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Korea, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 27, 2009

First Posted

May 28, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

April 16, 2010

Record last verified: 2010-04

Locations

KR(1)