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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Collaborator: Pronova BioPharma ASA

Criteria

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