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

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

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

Study Overview

• Status: Completed
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Omega-3 fatty acid ethylester90

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 Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omacor	Drug: Omega-3 fatty acid ethylester90; Dosage form :1g soft capsule Dosage : two capsules, twice a day.; Other Names: Omacor®
Placebo Comparator: Placebo Omacor	Drug: Omega-3 fatty acid ethylester90; Dosage form :1g soft capsule Dosage : two capsules, twice a day.; Other Names: Omacor®

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Kuhnil Pharmaceutical Co., Ltd.
• Collaborators: Pronova BioPharma ASA
• Investigators: Study Chair: Suhnggwon Kim, Professor, Seoul National University Hospital; Principal Investigator: Byung-Joo Park, MD,PhD,FISPE, Seoul National University College of Medicine

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: October 25, 2007
• First Submitted That Met QC Criteria: October 25, 2007
• First Posted (Estimate): October 26, 2007

Study Record Updates

• Last Update Posted (Estimate): September 27, 2012
• Last Update Submitted That Met QC Criteria: September 25, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: 06-OM-8301