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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00549692
First Posted: October 26, 2007
Last Update Posted: September 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pronova BioPharma ASA
Information provided by (Responsible Party):
Kuhnil Pharmaceutical Co., Ltd.
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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 ]
  • Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile [ Time Frame: 42 months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00549692


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

Responsible Party: Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00549692     History of Changes
Other Study ID Numbers: 06-OM-8301
First Submitted: October 25, 2007
First Posted: October 26, 2007
Last Update Posted: September 27, 2012
Last Verified: September 2012

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