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OpenTrials
Completed

NCT Number: NCT00459719

A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation

The patients about to undergo liver transplantation will be randomized to one of the following two group:

Group FK506MR: FK506MR/steroid; Group Prograf® : Prograf® /steroid The treatment period is 3 months(12 weeks

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Key information

Conditions

Liver Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent with the date of the patient must be obtained.
  • Patient between 18-70 years of age receiving the primary liver.
  • Female patients must have a negative pregnancy test prior to the enrolment.
  • Female patients of child bearing potential must agree to practice effective birth control during the study

Exclusion criteria

  • Liver re-transplantation patients or received an organ transplantation other than a liver.
  • Living-related liver transplantation patient.
  • Patient has received an AB0 incompatible donor liver.
  • Patient who needs antibody induction therapy.
  • Patient with sever infection requiring treatment.
  • Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy, liver cancer not included.

Treatment and study plan

Tacrolimus modified-release

Drug

oral

Other names: Advagraf, FK506MR, MR4

Prograf

Drug

oral

Other names: tacrolimus, FK506

Primary outcomes

  1. Event rate of patients with acute rejections

    Time frame: 12 Weeks

Secondary outcomes

  1. Incidence of and time to acute rejections

    Time frame: 12 Weeks

  2. Overall frequency of acute rejections

    Time frame: 12 Weeks

  3. Rate of patient and graft survival following transplantation.

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

A Multicenter, Randomized, Open Label, Parallel Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Combination With Steroids in Patients Undergoing Liver Transplantation and a Pharmacokinetics Study.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 12, 2007
Registry last updated
Feb 24, 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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