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

Liver Transplantation Clinical Trial

Official 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00459719
• Other study ID #: MR4LTxCN01
• Status: Completed
• Phase: Phase 3
• First received: April 10, 2007
• Last updated: February 23, 2016
• Start date: March 2007
• Est. completion date: March 2009

Study information

• Verified date: February 2016
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Tacrolimus modified-release
oral
• Prograf
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event rate of patients with acute rejections		12 Weeks	Yes
Secondary	Incidence of and time to acute rejections		12 Weeks	Yes
Secondary	Overall frequency of acute rejections		12 Weeks	Yes
Secondary	Rate of patient and graft survival following transplantation.		12 weeks	Yes