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

IgA Nephropathy Clinical Trial

— IgAN  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00549692
• Other study ID #: 06-OM-8301
• Status: Completed
• Phase: Phase 3
• First received: October 25, 2007
• Last updated: September 25, 2012
• Start date: November 2007
• Est. completion date: September 2012

Study information

• Verified date: September 2012
• Source: Kuhnil Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Drug:
• Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyeonggi-do
Korea, Republic of	Kangnam St. May's Hospital	Seoul
Korea, Republic of	Kyhung Hee University medical center	Seoul
Korea, Republic of	Samsumg Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Kuhnil Pharmaceutical Co., Ltd.	Pronova BioPharma ASA

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of number of patients that 50% or more increase in SCr after 42 months		42 months	No
Secondary	The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months		42 months	No
Secondary	Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile		42 months	Yes