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Trial record 1 of 1 for:    NCT00481819
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A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00481819
Recruitment Status : Completed
First Posted : June 4, 2007
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

Brief Summary:

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 or disease Intervention/treatment Phase
Kidney Transplantation Drug: FK506MR Drug: Prograf Drug: Mycophenolate Mofetil Drug: Methylprednisolone Drug: Prednisolone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
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.
Study Start Date : July 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
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

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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00481819

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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
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Principal Investigator: Prof. Ao Jianhua Department of Urologic Surgery
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Responsible Party: Astellas Pharma Inc Identifier: NCT00481819    
Other Study ID Numbers: MR4KTxCN01
First Posted: June 4, 2007    Key Record Dates
Last Update Posted: February 24, 2016
Last Verified: February 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:
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Mycophenolic Acid
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone 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
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents