NCT01339468

Brief Summary

The purpose of this study is to investigate and compare the pharmacokinetic parameters of tacrolimus from Advagraf and Prograf in de nove living donor liver transplant recipients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

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

First Submitted

Initial submission to the registry

April 12, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
7 days until next milestone

Study Start

First participant enrolled

April 27, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2014

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

3.1 years

First QC Date

April 12, 2011

Last Update Submit

July 17, 2017

Conditions

Liver Transplantation

Keywords

advagrafprografliving donor liver transplantationFK506Immunosuppressant

Outcome Measures

Primary Outcomes (1)

  • AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration

    Day 6 and day 21

Secondary Outcomes (4)

  • Cmax (maximum concentration) of tacrolimus plasma concentration

    Day 6 and day 21

  • Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)

    up to 24 weeks

  • Time to first incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)

    up to 24 weeks

  • Safety assessed by the incidence of adverse events and lab-tests

    up to 24 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Intravenous Prograf therapy followed by oral Advagraf therapy

Drug: AdvagrafDrug: Prograf

Arm 2

ACTIVE COMPARATOR

Intravenous Prograf therapy followed by oral Prograf therapy

Drug: Prograf

Interventions

AdvagrafDRUG

oral

Also known as: FK506E, modified release tacrolimus
Arm 1
PrografDRUG

oral

Also known as: FK506, tacrolimus
Arm 2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject receiving a primary, partial liver graft from a living donor
  • subject must receive the first dose of tacrolimus and corticosteroids after operation and are expected to be maintained on tacrolimus throughout the study. MMF could be combined

You may not qualify if:

  • subjects receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation)
  • subjects receiving an auxiliary graft or in whom a bio-artificial liver (cell system) has been used
  • subjects allergic or intolerant to macrolide antibiotics or tacrolimus
  • subjects requiring immunosuppressive treatment and / or systemic chemotherapy prior to transplantation
  • subjects with malignancies or a history of malignancy within the last 5 years, with the exception of those with basalioma or squamous cell carcinoma of the skin
  • subjects with systemic infection requiring treatment, except viral hepatitis
  • subjects with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus
  • subjects with serum creatinine \> 1.5mg/dl
  • subjects taking or having taken potassium preserved diuretics
  • subjects with any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator, may complicate communication with the investigator
  • subjects participating or having participated in another clinical trial and/or those taking or having taken an investigational / non-registered drug in the past 28 days
  • subjects or donors known to be HIV positive
  • donors known to be HBV, HCV positive and/or IgM positive of CMV, EBV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

  • Shin MH, Song GW, Lee SG, Hwang S, Kim KH, Ahn CS, Moon DB, Ha TY, Jung DH, Park GC, Yun YI, Kim WJ, Kang WH, Kim SH, Jiang H, Lee S, Tak EY. Once-daily, prolonged-release tacrolimus vs twice-daily, immediate-release tacrolimus in de novo living-donor liver transplantation: A Phase 4, randomized, open-label, comparative, single-center study. Clin Transplant. 2018 Sep;32(9):e13376. doi: 10.1111/ctr.13376. Epub 2018 Aug 26.

    PMID: 30098071DERIVED

Related Links

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Use Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2011

First Posted

April 20, 2011

Study Start

April 27, 2011

Primary Completion

May 27, 2014

Study Completion

May 27, 2014

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

KR(1)