Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy

Study Overview
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Brief Summary
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The purpose of this study is to compare omega-3 fatty acids with placebo for efficacy in retardation of increase of serum creatinine(SCr) in IgA Nephropathy

Detailed Description
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In the current clinical study, attempts are made to assess the safety and efficacy of omega-3 fatty acids by comparing between omega-3 fatty acids and the placebo in Korean patients with IgA nephropathy.

Official 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

Conditions
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IgA Nephropathy

Intervention / Treatment
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* Drug: Omega-3 fatty acid ethylester90


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Omacor<br> | Drug: Omega-3 fatty acid ethylester90<br>* Dosage form :1g soft capsule Dosage : two capsules, twice a day.<br>* Other names: Omacor®;|
| Placebo Comparator: Placebo Omacor<br> | Drug: Omega-3 fatty acid ethylester90<br>* Dosage form :1g soft capsule Dosage : two capsules, twice a day.<br>* Other names: Omacor®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of number of patients that 50% or more increase in SCr after 42 months |  | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months |  | 42 months | 
| Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile |  | 42 months |