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

This study has been completed.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: May 31, 2007
Last updated: February 23, 2016
Last verified: February 2016

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)

Condition Intervention Phase
Kidney Transplantation Drug: FK506MR Drug: Prograf Drug: Mycophenolate Mofetil Drug: Methylprednisolone Drug: Prednisolone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with acute rejections [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Incidence of and time to acute rejections [ Time Frame: 12 Weeks ]
  • Overall frequency of acute rejections [ Time Frame: 12 Weeks ]
  • Rate of patient and graft survival following transplantation [ Time Frame: 12 Weeks ]

Enrollment: 240
Study Start Date: July 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
In combination with MMF and steroids
Drug: FK506MR
Other Names:
  • Advagraf
  • Tacrolimus modified-release
  • MR4
Drug: Mycophenolate Mofetil
Other Name: MMF
Drug: Methylprednisolone
Drug: Prednisolone
Active Comparator: 2
In combination with MMF and steroids
Drug: Prograf
Other Names:
  • tacrolimus
  • FK506
Drug: Mycophenolate Mofetil
Other Name: MMF
Drug: Methylprednisolone
Drug: Prednisolone


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00481819

China, Beijing
3 Sites
Beijing, Beijing, China
China, Fujian
Fuzhou, Fujian, China
China, Guangdong
2 Sites
Guangzhou, Guangdong, China
China, Hubei
Wuhan, Hubei, China
China, Hunan
Changsha, Hunan, China
China, Liaoning
Shenyang, Liaoning, China
China, Shanghai
2 Sites
Shanghai, Shanghai, China
China, Sichuan
Chongqing, Sichuan, China
China, Zhejiang
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Principal Investigator: Prof. Ao Jianhua Department of Urologic Surgery
  More Information

Responsible Party: Astellas Pharma Inc Identifier: NCT00481819     History of Changes
Other Study ID Numbers: MR4KTxCN01
Study First Received: May 31, 2007
Last Updated: February 23, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Mycophenolate Mofetil

Additional relevant MeSH terms:
Mycophenolate mofetil
Mycophenolic Acid
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents processed this record on August 18, 2017