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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.
Sponsor:
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00481819
First received: May 31, 2007
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Event rate of patients with acute rejections [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

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

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
oral
Other Names:
  • Advagraf
  • Tacrolimus modified-release
  • MR4
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: Methylprednisolone
oral
Drug: Prednisolone
oral
Active Comparator: 2
In combination with MMF and steroids
 Drug: Prograf
oral
Other Names:
  • tacrolimus
  • FK506
Drug: Mycophenolate Mofetil
oral
Other Name: MMF
Drug: Methylprednisolone
oral
Drug: Prednisolone
oral

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00481819

Locations
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, Zheijiang
Hangzhou, Zheijiang, China
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Principal Investigator: Prof. Ao Jianhua Department of Urologic Surgery
  More Information

No publications provided

Responsible Party: Director, Astellas Pharma, Inc
ClinicalTrials.gov Identifier: NCT00481819     History of Changes
Other Study ID Numbers: MR4KTxCN01
Study First Received: May 31, 2007
Last Updated: March 10, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Kidney Transplantation
Tacrolimus
Methylprednisolone
Prednisolone
Mycophenolate Mofetil

Additional relevant MeSH terms:
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Mycophenolic Acid
Mycophenolate mofetil
Tacrolimus
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Antibiotics, Antineoplastic
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013