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

Phase 3

Completed

• Conditions: IgA Nephropathy
• Interventions: Drug: Omega-3 fatty acid ethylester90

• Registration Number: NCT00549692
• Lead Sponsor: Kuhnil Pharmaceutical Co., Ltd.

Brief 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

Detailed 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.

Study Timeline

• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Study Start: 2007-11
• Primary Completion: 2012-08
• Status Verified: 2012-09
• Study Completion: 2012-09
• Last Update Submitted: 2012-09-25
• Last Update Posted: 2012-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Omacor	Omega-3 fatty acid ethylester90	-
Placebo Omacor	Omega-3 fatty acid ethylester90	-

Primary Outcome Measures

Name	Time	Method
The rate of number of patients that 50% or more increase in SCr after 42 months	42 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Kyeonggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyhung Hee University medical center; 🇰🇷 Seoul, Korea, Republic of

Kangnam St. May's Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsumg Medical Center; 🇰🇷 Seoul, Korea, Republic of