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

Astellas

Status and phase: Completed; Phase 3

Conditions: Liver Transplantation

Treatments: Drug: Prograf; Drug: Tacrolimus modified-release

Study type: Interventional

Funder types: Industry

Identifiers

NCT00459719

MR4LTxCN01

Details and patient eligibility

About

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

Enrollment: 42 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

1

Experimental group

Description:

In combination with steroids

Treatment:

Drug: Tacrolimus modified-release

2

Active Comparator group

Description:

In combination with steroids

Treatment:

Drug: Prograf