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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 16, 2014