Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy (IgAN)
Primary Purpose
IgA Nephropathy
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Omega-3 fatty acid ethylester90
Sponsored by
About this trial
This is an interventional prevention trial for 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
Sites / Locations
- Seoul National University Bundang Hospital
- Seoul National University Hospital
- Kyhung Hee University medical center
- Samsumg Medical Center
- Kangnam St. May's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Omacor
Placebo Omacor
Arm Description
Outcomes
Primary Outcome Measures
The rate of number of patients that 50% or more increase in SCr after 42 months
Secondary Outcome Measures
The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile
Full Information
NCT ID
NCT00549692
First Posted
October 25, 2007
Last Updated
September 25, 2012
Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Pronova BioPharma ASA
1. Study Identification
Unique Protocol Identification Number
NCT00549692
Brief Title
Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
Acronym
IgAN
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Pronova BioPharma ASA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IgA Nephropathy
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
152 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Omacor
Arm Type
Experimental
Arm Title
Placebo Omacor
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Omega-3 fatty acid ethylester90
Other Intervention Name(s)
Omacor®
Intervention Description
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
Primary Outcome Measure Information:
Title
The rate of number of patients that 50% or more increase in SCr after 42 months
Time Frame
42 months
Secondary Outcome Measure Information:
Title
The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months
Time Frame
42 months
Title
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile
Time Frame
42 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suhnggwon Kim, Professor
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Byung-Joo Park, MD,PhD,FISPE
Organizational Affiliation
Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-740
Country
Korea, Republic of
Facility Name
Kyhung Hee University medical center
City
Seoul
ZIP/Postal Code
130-702
Country
Korea, Republic of
Facility Name
Samsumg Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Kangnam St. May's Hospital
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
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