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

Kuhnil Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

IgA Nephropathy

Treatments

Drug: Omega-3 fatty acid ethylester90

Study type

Interventional

Funder types

Industry

Identifiers

NCT00549692

06-OM-8301

Details and patient eligibility

About

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

Full description

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.

Enrollment

152 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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