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

This study has been completed.
Sponsor:
Collaborator:
Pronova BioPharma ASA
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00549692
First received: October 25, 2007
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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


Condition Intervention Phase
IgA Nephropathy
Drug: Omega-3 fatty acid ethylester90
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Kuhnil Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The rate of number of patients that 50% or more increase in SCr after 42 months [ Time Frame: 42 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months [ Time Frame: 42 months ] [ Designated as safety issue: No ]
  • Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile [ Time Frame: 42 months ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: November 2007
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omacor Drug: Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Other Name: Omacor®
Placebo Comparator: Placebo Omacor Drug: Omega-3 fatty acid ethylester90
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Other Name: Omacor®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549692

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, Korea, Republic of, 463-707
Kyhung Hee University medical center
Seoul, Korea, Republic of, 130-702
Kangnam St. May's Hospital
Seoul, Korea, Republic of, 137-701
Samsumg Medical Center
Seoul, Korea, Republic of, 135-710
Seoul National University Hospital
Seoul, Korea, Republic of, 110-740
Sponsors and Collaborators
Kuhnil Pharmaceutical Co., Ltd.
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
  More Information

No publications provided

Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00549692     History of Changes
Other Study ID Numbers: 06-OM-8301
Study First Received: October 25, 2007
Last Updated: September 25, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)
South Korea: Institutional Review Board

Additional relevant MeSH terms:
Glomerulonephritis, IGA
Kidney Diseases
Glomerulonephritis
Nephritis
Urologic Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 16, 2014