NCT00619398

Brief Summary

This study aims to evaluate and to compare the efficacy and safety of FK506MR with Prograf® in stable liver transplantation patients. It shall be demonstrated that FK506MR is non-inferior to Prograf® with regards to the efficacy and safety.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

January 23, 2008

Completed
29 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

February 24, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

January 23, 2008

Last Update Submit

February 23, 2016

Conditions

Liver Transplantation

Keywords

FK506tacrolimusprografLiver transplantation

Outcome Measures

Primary Outcomes (1)

  • Event rate of patients with acute rejections

    12 Weeks

Secondary Outcomes (4)

  • Incidence of and time to acute rejections

    12 Weeks

  • Overall frequency of acute rejections

    12 Weeks

  • Rate of patients and graft survival following transplantation

    12 Weeks

  • Incidence of adverse events including laboratory assessments

    12 Weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: Prograf

2

EXPERIMENTAL
Drug: FK506MR capsule

Interventions

PrografDRUG

Oral

Also known as: tacrolimus, FK506
1
FK506MR capsuleDRUG

Oral

Also known as: Advagraf, tacrolimus modified release capsule, MR4, Prograf XL
2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent with the date of the patient must be obtained
  • Patient is the recipient of a liver transplant from 6 to 24 months prior to enrollment
  • Patient is currently receiving Prograf or Prograf + MMF based immunosuppressive therapy
  • At screening the liver and kidney function of patient is stable (defined as Serum creatinine is normal and ALT or AST is \<= 2 times the upper value of normal range)
  • Patient has the stable whole blood trough level concentration of Prograf (defined as tacrolimus trough concentrations of 2-10ng/ml measured 14 days prior to enrollment), and is clinically stable in the opinion of the investigator

You may not qualify if:

  • Patient has received an organ transplant other than a kidney
  • Patient has experienced any rejection episode within 90 days prior to enrollment in the study, any rejection episode within the last 6 months that required anti-lymphocyte antibody therapy
  • Patient is currently receiving other immunosuppressant therapy, eg. sirolimus
  • Patient with liver recurrent cancer, or metastasis, or other cancer
  • Patient has any unstable medical condition that could interfere with the study objectives
  • Patient is currently participating in another clinical trial and/or is taking or has been taking an investigational drug in the 30 days prior to enrollment
  • Patient is allergic macrolide antibiotics or tacrolimus
  • Patient has psychiatric disorder, in the opinion of the investigator, may invalidate communication with the investigator
  • Patient is currently receiving any medications, which is know to alter the CYP450 3A enzyme system (including grapefruit juice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Beijing, Beijing Municipality, China

Location

Unknown Facility

Guangzhou, Guangdong, China

Location

Unknown Facility

Shenyang, Liaoning, China

Location

Unknown Facility

Shanghai, Shanghai Municipality, China

Location

Unknown Facility

Hangzhou, Zhejiang, China

Location

Unknown Facility

Tianjing, China

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2008

First Posted

February 21, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

February 24, 2016

Record last verified: 2016-02

Locations

CN(6)