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Completed

NCT Number: NCT00549692

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam, Kyeonggi-do, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 fatty acid ethylester90

Drug

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

Other names: Omacor®

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

Sponsors and collaborators

Lead sponsor

Kuhnil Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Pronova BioPharma ASA

Registry information

Official study 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

Acronym: IgAN

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 26, 2007
Registry last updated
Sep 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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