A Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf and Prograf in de Novo Liver Transplantation (MAIN)

July 17, 2017 updated by: Astellas Pharma Inc

A Phase IV, Randomized, Open-label, Comparative, Single-center Study to Assess the Pharmacokinetics, Safety and Efficacy of Advagraf® (Modified Release Tacrolimus) and Prograf® (Tacrolimus) in de Novo Living Donor Liver Transplant Recipients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Intravenous Prograf therapy followed by oral Advagraf therapy
Drug: Prograf
oral
Other Names:
  • FK506
  • tacrolimus
Drug: Advagraf
oral
Other Names:
  • FK506E
  • modified release tacrolimus
Drug: Prograf
intravenous
Other Names:
  • FK506
  • tacrolimus
Active Comparator: Arm 2
Intravenous Prograf therapy followed by oral Prograf therapy
Drug: Prograf
oral
Other Names:
  • FK506
  • tacrolimus
Drug: Prograf
intravenous
Other Names:
  • FK506
  • tacrolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC0-24 (Area under the curve for 24 hours) of tacrolimus plasma concentration
Time Frame: Day 6 and day 21
Day 6 and day 21

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax (maximum concentration) of tacrolimus plasma concentration
Time Frame: Day 6 and day 21
Day 6 and day 21
Incidence of the composite event: graft loss (defined as re-transplantation or death) or biopsy confirmed acute rejection (BCAR)
Time Frame: up to 24 weeks
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)
Time Frame: up to 24 weeks
up to 24 weeks
Safety assessed by the incidence of adverse events and lab-tests
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2011

Primary Completion (Actual)

May 27, 2014

Study Completion (Actual)

May 27, 2014

Study Registration Dates

First Submitted

April 12, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (Estimate)

April 20, 2011

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 17, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-08-04-KOR_Main

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Transplantation

Clinical Trials on Prograf

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe