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

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

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

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.

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