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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00549692 |
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Date of registration:
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25/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
IgAN |
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Scientific title:
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Minimization, Double-blind, Placebo-controlled, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy |
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Date of first enrolment:
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November 2007 |
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Target sample size:
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152 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00549692 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 3
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Suhnggwon Kim, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University Hospital |
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Name:
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Byung-Joo Park, MD,PhD,FISPE |
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Address:
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Telephone:
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Email:
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Affiliation:
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Seoul National University College of Medicine |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient of both sexes age 18 or above
- Biopsy-proven IgA nephropathy
- Baseline serum creatinine = 1.2mg/dl(Female),= 1.4mg/dl(Male)
- Able to give written informed consent
Exclusion Criteria:
- Hypertension SBP>160mmHg and/or DBP>100mmHg
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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IgA Nephropathy
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Intervention(s)
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Drug: Omega-3 fatty acid ethylester90
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Primary Outcome(s)
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The rate of number of patients that 50% or more increase in SCr after 42 months
[Time Frame: 42 months]
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Secondary Outcome(s)
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Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile
[Time Frame: 42 months]
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The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months
[Time Frame: 42 months]
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Secondary ID(s)
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06-OM-8301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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