A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation
NCT ID: NCT00481819
Last Updated: 2016-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
240 participants
INTERVENTIONAL
2007-07-31
2009-03-31
Brief Summary
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Group FK506MR: FK506MR/MMF/steroid; Group Prograf® : Prograf® /MMF/steroid. The treatment period is 3 months( 12 weeks)
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
In combination with MMF and steroids
FK506MR
oral
Mycophenolate Mofetil
oral
Methylprednisolone
oral
Prednisolone
oral
2
In combination with MMF and steroids
Prograf
oral
Mycophenolate Mofetil
oral
Methylprednisolone
oral
Prednisolone
oral
Interventions
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FK506MR
oral
Prograf
oral
Mycophenolate Mofetil
oral
Methylprednisolone
oral
Prednisolone
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Ao Jianhua
Role: PRINCIPAL_INVESTIGATOR
Department of Urologic Surgery
Locations
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3 Sites
Beijing, Beijing Municipality, China
Fuzhou, Fujian, China
2 Sites
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Changsha, Hunan, China
Shenyang, Liaoning, China
2 Sites
Shanghai, Shanghai Municipality, China
Chongqing, Sichuan, China
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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MR4KTxCN01
Identifier Type: -
Identifier Source: org_study_id
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