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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
Kuhnil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for IgA Nephropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 25, 2007
Last Updated
September 25, 2012
Sponsor
Kuhnil Pharmaceutical Co., Ltd.
Collaborators
Pronova BioPharma ASA
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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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