Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
NCT ID: NCT00549692
Last Updated: 2012-09-27
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
152 participants
INTERVENTIONAL
2007-11-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Omacor
Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Placebo Omacor
Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Interventions
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Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biopsy-proven IgA nephropathy
* Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male)
* Able to give written informed consent
Exclusion Criteria
* Subject, who in the investigator's opinion, has a systemic disease that would contraindicate participation in this study
* Use of omega-3 fatty acids or analog supplement
* Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception
* Current or recent (within 30 days) exposure to any investigational drug
* Subject who has hypersensitivity to this agent as a previous illness
* Low platelet(\<100,000/㎕) or the subject who has a high risk of bleeding
* Use of corticosteroid during the treatment period or less than 3 months prior to the screening
* Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening
* Subject who in the investigator's opinion, would be confronted with a difficulty
18 Years
ALL
No
Sponsors
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Pronova BioPharma ASA
INDUSTRY
Kuhnil Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Suhnggwon Kim, Professor
Role: STUDY_CHAIR
Seoul National University Hospital
Byung-Joo Park, MD,PhD,FISPE
Role: PRINCIPAL_INVESTIGATOR
Seoul National University College of Medicine
Locations
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Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Kyhung Hee University medical center
Seoul, , South Korea
Samsumg Medical Center
Seoul, , South Korea
Kangnam St. May's Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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06-OM-8301
Identifier Type: -
Identifier Source: org_study_id