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OpenTrials
Completed

NCT Number: NCT01018914

A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

To compare the safety and efficacy of Prograf® with Myfortic® to Advagraf® extended release tacrolimus with Myfortic® in de novo liver transplant recipients.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Taichung, Taiwan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient is a primary liver transplant recipient
  • Female patients of child bearing potential must have a negative urine or serum pregnancy test within 7 days prior to transplant
  • Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures
  • Patient must receive 1st dose of study drug within 24 hours of pre-transplantation

Exclusion criteria

  • Patient has previously received or is receiving an organ transplant other than a liver
  • Patient currently requires dialysis
  • Patient has received a liver transplant from a non-heart beating donor
  • Patient has received an ABO incompatible donor liver
  • Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV)
  • Patient has fulminant hepatic failure, unless hemodynamically stable
  • Patient has an uncontrolled concomitant infection, a systemic infection requiring treatment (except viral hepatitis), or any other unstable medical condition that could interfere with the study objectives
  • Patient is currently taking or has been taking an investigational drug in the 30 days prior to transplant
  • Patient has a known hypersensitivity to tacrolimus, enteric-coated mycophenolate sodium or corticosteroids
  • Patient is pregnant or lactating

Treatment and study plan

Prograf

Drug

oral

Other names: Tacrolimus, FK506

Advagraf

Drug

oral

Other names: Extended release tacrolimus, FK506E, MR4

Myfortic

Drug

oral

Other names: Mycophenolate sodium

Primary outcomes

  1. Incidence of biopsy confirmed acute rejection

    Time frame: during the 6 months post-transplant.

Secondary outcomes

  1. Patient and graft survival rates

    Time frame: during the 6 months post-transplant

  2. Time to first biopsy confirmed acute rejection episode

    Time frame: during the 6 months post-transplant

  3. Incidence of anti-lymphocyte antibody therapy for treatment of rejection

    Time frame: during the 6 months post-transplant.

  4. Safety assessed by adverse events, laboratory parameters, physical examinations and vital signs

    Time frame: throughout the study

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Taiwan, Inc.

Registry information

Official study title

A Randomized, Open-Label, Comparative, Multi-Center Study to Assess the Safety and Efficacy of Prograf® (Tacrolimus)/ Myfortic® and Advagraf® (Extended Release Tacrolimus) / Myfortic® in de Novo Liver Transplant Recipients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2009
Registry last updated
Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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