Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2026-02-27 @ 8:27 AM
Study NCT ID:
NCT00549692
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2007-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C405603', 'term': 'Omacor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-25', 'studyFirstSubmitDate': '2007-10-25', 'studyFirstSubmitQcDate': '2007-10-25', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of number of patients that 50% or more increase in SCr after 42 months', 'timeFrame': '42 months'}], 'secondaryOutcomes': [{'measure': 'The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months', 'timeFrame': '42 months'}, {'measure': 'Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile', 'timeFrame': '42 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['IgA Nephropathy']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient of both sexes age 18 or above\n* Biopsy-proven IgA nephropathy\n* Baseline serum creatinine ≥ 1.2mg/dl(Female),≥ 1.4mg/dl(Male)\n* Able to give written informed consent\n\nExclusion Criteria:\n\n* Hypertension SBP\\>160mmHg and/or DBP\\>100mmHg\n* Subject, who in the investigator's opinion, has a systemic disease that would contraindicate participation in this study\n* Use of omega-3 fatty acids or analog supplement\n* Pregnancy or breast feeding at time of entry or unwillingness to comply with measures for contraception\n* Current or recent (within 30 days) exposure to any investigational drug\n* Subject who has hypersensitivity to this agent as a previous illness\n* Low platelet(\\<100,000/㎕) or the subject who has a high risk of bleeding\n* Use of corticosteroid during the treatment period or less than 3 months prior to the screening\n* Use of anticoagulant during the treatment period or within 1 month or 6 half lives prior to screening\n* Subject who in the investigator's opinion, would be confronted with a difficulty"}, 'identificationModule': {'nctId': 'NCT00549692', 'acronym': 'IgAN', 'briefTitle': 'Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kuhnil Pharmaceutical Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '06-OM-8301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Omacor', 'interventionNames': ['Drug: Omega-3 fatty acid ethylester90']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Omacor', 'interventionNames': ['Drug: Omega-3 fatty acid ethylester90']}], 'interventions': [{'name': 'Omega-3 fatty acid ethylester90', 'type': 'DRUG', 'otherNames': ['Omacor®'], 'description': 'Dosage form :1g soft capsule Dosage : two capsules, twice a day.', 'armGroupLabels': ['Omacor', 'Placebo Omacor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '463-707', 'city': 'Seongnam', 'state': 'Kyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '110-740', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '130-702', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyhung Hee University medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '135-710', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsumg Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '137-701', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Kangnam St. May's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Suhnggwon Kim, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Seoul National University Hospital'}, {'name': 'Byung-Joo Park, MD,PhD,FISPE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuhnil Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pronova BioPharma ASA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}