Clinical trial NCT00549692: Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: IgA Nephropathy
Lead sponsor: Kuhnil Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Pronova BioPharma ASA
First posted: 2007-10-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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: 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 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

Primary outcomes:
measure: The rate of number of patients that 50% or more increase in SCr after 42 months
timeFrame: 42 months
Secondary outcomes:
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
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Kyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyhung Hee University medical center
city: Seoul
country: Korea, Republic of
facility: Samsumg Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangnam St. May's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Suhnggwon Kim, Professor
role: STUDY_CHAIR
affiliation: Seoul National University College of Medicine
name: Byung-Joo Park, MD,PhD,FISPE
role: PRINCIPAL_INVESTIGATOR
References: