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

NCT00549692 | Completed Phase 3

• 1 other identifier: 06-OM-8301
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 5

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

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

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

  42 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Omacor

EXPERIMENTAL

Drug: Omega-3 fatty acid ethylester90

Placebo Omacor

PLACEBO COMPARATOR

Drug: Omega-3 fatty acid ethylester90

Interventions

Omega-3 fatty acid ethylester90 DRUG

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

Also known as: Omacor®

Omacor; Placebo Omacor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kuhnil Pharmaceutical Co., Ltd.: lead
• Pronova BioPharma ASA: collaborator

Study Sites (5)

Seoul National University Bundang Hospital

Seongnam, Kyeonggi-do, 463-707, South Korea

Location

Seoul National University Hospital

Seoul, 110-740, South Korea

Location

Kyhung Hee University medical center

Seoul, 130-702, South Korea

Location

Samsumg Medical Center

Seoul, 135-710, South Korea

Location

Kangnam St. May's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Omacor

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Suhnggwon Kim, Professor

  Seoul National University Hospital

  STUDY CHAIR

• Byung-Joo Park, MD,PhD,FISPE

  Seoul National University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2007
• First Posted: October 26, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2012
• Study Completion: September 1, 2012
• Last Updated: September 27, 2012

Record last verified: 2012-09

Locations

KR (5)