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

Tracking Information

First Received Date ^ICMJE

October 25, 2007

Last Updated Date

October 21, 2008

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

The rate of number of patients that 50% or more increase in SCr after 24 months [ Time Frame: Two years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The rate of number of patients that 50% or more increase in SCr after 24 months [ Time Frame: Two years ]

Change History

Complete list of historical versions of study NCT00549692 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

The rate of number of patients that 50% or more increase in SCr after 6 and 12 months [ Time Frame: Two years ] [ 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: 2 years ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The rate of number of patients that 50% or more increase in SCr after 6 and 12 months [ Time Frame: Two years ]
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albimin/Creatinine ratio, serum Cystatin C, Lipid profile [ Time Frame: 2 years ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

IGA Nephropathy

Intervention ^ICMJE

Drug: Omega-3 fatty acid ethylester90

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

September 2010

Estimated Primary Completion Date

June 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Korea, Republic of

Administrative Information

NCT ID ^ICMJE

NCT00549692

Responsible Party

Dong-Jae Choi/Executive Director, Kuhnil Pharmaceutical Co., Ltd.

Study ID Numbers ^ICMJE

06-OM-8301

Study Sponsor ^ICMJE

Kuhnil Pharmaceutical Co., Ltd.

Collaborators ^ICMJE

Pronova BioPharma ASA

Investigators ^ICMJE

Study Chair:	Suhnggwon Kim, Professor	Seoul National University Hospital
Principal Investigator:	Byung-Joo Park, MD,PhD,FISPE	Seoul National University College of Medicine

Information Provided By

Kuhnil Pharmaceutical Co., Ltd.

Verification Date

October 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP