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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549692

Acronym

IgAN

Enrollment

152

Registered

2007-10-26

Start date

2007-11-30

Completion date

2012-09-30

Last updated

2012-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IgA Nephropathy

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.

Interventions

DRUGOmega-3 fatty acid ethylester90

Dosage form :1g soft capsule Dosage : two capsules, twice a day.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile	42 months
The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months	42 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026