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CompletedNCT00549692IgANUpdated Sep 27, 2012

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

A Phase 3 interventional study of Omega-3 fatty acid ethylester90 in IgA Nephropathy, sponsored by Kuhnil Pharmaceutical Co., Ltd.. Completed at 5 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-09-27.

Sponsored by Kuhnil Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
152
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • IgA Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 152 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Kuhnil Pharmaceutical Co., Ltd. is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
152 participants (actual)

Study arms

  • Experimental
    Omacor

    Drug: Omega-3 fatty acid ethylester90

  • Placebo comparator
    Placebo Omacor

    Drug: Omega-3 fatty acid ethylester90

Interventions

  • DrugOmega-3 fatty acid ethylester90

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

    Also known as: Omacor®

06

What researchers measure

Primary outcomes

  1. The rate of number of patients that 50% or more increase in SCr after 42 months

    Time frame: 42 months

Secondary outcomes

  1. The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months

    Time frame: 42 months

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

    Time frame: 42 months

07

Study locations

5 sites
  • Seoul National University Bundang Hospital
    Seongnam, Kyeonggi-do 463-707, Korea, Republic of
  • Seoul National University Hospital
    Seoul, 110-740, Korea, Republic of
  • Kyhung Hee University medical center
    Seoul, 130-702, Korea, Republic of
  • Samsumg Medical Center
    Seoul, 135-710, Korea, Republic of
  • Kangnam St. May's Hospital
    Seoul, 137-701, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00549692
Lead sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Pronova BioPharma ASA
Responsible party
Sponsor
First posted
Oct 26, 2007
Start date
Nov 2007
Primary completion
Aug 2012
Completion
Sep 2012
Last update
Sep 27, 2012

Study contacts

Suhnggwon Kim, Professor
study chair · Seoul National University Hospital
Byung-Joo Park, MD,PhD,FISPE
principal investigator · Seoul National University College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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