Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy

Condition(s) targeted: IGA Nephropathy

Intervention: Omega-3 fatty acid ethylester90 (Drug)

Phase: Phase 3

Status: Enrolling by invitation

Sponsored by: Kuhnil Pharmaceutical Co., Ltd.

Official(s) and/or principal investigator(s):
Suhnggwon Kim, Professor, Study Chair, Affiliation: Seoul National University Hospital
Byung-Joo Park, MD,PhD,FISPE, Principal Investigator, Affiliation: Seoul National University College of Medicine

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

Official title: 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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The rate of number of patients that 50% or more increase in SCr after 24 months

Secondary outcome:

The rate of number of patients that 50% or more increase in SCr after 6 and 12 months

Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Kyhung Hee University medical center, Seoul 130-702, Korea, Republic of

Kangnam St. May's Hospital, Seoul 137-701, Korea, Republic of

Samsumg Medical Center, Seoul 135-710, Korea, Republic of

Seoul National University Hospital, Seoul 110-740, Korea, Republic of

Seoul National University Bundang Hospital, Seongnam, Kyeonggi-do 463-707, Korea, Republic of

Starting date: November 2007
Ending date: September 2010
Last updated: December 27, 2007