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

February 23, 2016 updated by: Astellas Pharma Inc

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

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • 3 Sites
    • Fujian
      • Fuzhou, Fujian, China
    • Guangdong
      • Guangzhou, Guangdong, China
        • 2 Sites
    • Hubei
      • Wuhan, Hubei, China
    • Hunan
      • Changsha, Hunan, China
    • Liaoning
      • Shenyang, Liaoning, China
    • Shanghai
      • Shanghai, Shanghai, China
        • 2 Sites
    • Sichuan
      • Chongqing, Sichuan, China
    • Zhejiang
      • Hangzhou, Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Written informed consent with the date of the patient must be obtained.
  • Patient between 18-70 years of age receiving the primary kidney.
  • 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:

  • Kidney re-transplantation patients or received an organ transplantation other than a kidney.
  • PRA>10% in the previous 6 months.
  • Patient who need antibody induction therapy.
  • Patient with significant liver disease, defined as having continuously elevated >2 times of SGPT and/or SGOT and/or total bilirubin levels during the past 28 days.
  • Patient with severe infection requiring treatment, and/or severe diarrhea, vomiting, active upper gastrointestinal tract malabsorption or active peptic ulcer.
  • Patient has any history of severe cardiovascular, respiratory disease; or history of malignancy.
  • Patient is HIV or HBsAg positive.
  • Patient is allergic to Prograf or macrolide antibiotics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
In combination with MMF and steroids
Drug: Mycophenolate Mofetil
oral
Other Names:
  • MMF
Drug: FK506MR
oral
Other Names:
  • Advagraf
  • MR4
  • Tacrolimus modified-release
Drug: Methylprednisolone
oral
Drug: Prednisolone
oral
Active Comparator: 2
In combination with MMF and steroids
Drug: Mycophenolate Mofetil
oral
Other Names:
  • MMF
Drug: Prograf
oral
Other Names:
  • FK506
  • tacrolimus
Drug: Methylprednisolone
oral
Drug: Prednisolone
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event rate of patients with acute rejections
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of and time to acute rejections
Time Frame: 12 Weeks
12 Weeks
Overall frequency of acute rejections
Time Frame: 12 Weeks
12 Weeks
Rate of patient and graft survival following transplantation
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Principal Investigator: Prof. Ao Jianhua, Department of Urologic Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 4, 2007

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

February 23, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR4KTxCN01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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