Study to Evaluate the Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of IgA Nephropathy - Full Text View

Sponsor:	Kuhnil Pharmaceutical Co., Ltd.
Collaborator:	Pronova BioPharma ASA
Information provided by (Responsible Party):	Kuhnil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00549692

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 III

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:

Drug Information available for: Docosahexaenoic acids Eicosapentaenoic acid Omacor

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Omega-3 fatty acid ethylester90 Dosage form :1g soft capsule Dosage : two capsules, twice a day. Other Name: Omacor®
Placebo Comparator: 2	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:	November 7, 2011
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 February 09, 2012