IgA NephropathyPhase 3IgANNCT00549692
Efficacy and Safety of Omega-3 Fatty Acids(Omacor®) for the Treatment of Immunoglobulin A Nephropathy
A Phase 3 study testing Omega-3 fatty acid ethylester90 in people with IgA Nephropathy, run by Kuhnil Pharmaceutical Co., Ltd. at 5 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Omega-3 fatty acid ethylester90
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Nov 2007to Sep 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Seoul National University Bundang Hospital
Seongnam, Kyeonggi-do, 463-707
Seoul National University Hospital
Seoul, 110-740
Kyhung Hee University medical center
Seoul, 130-702
Samsumg Medical Center
Seoul, 135-710
Kangnam St. May's Hospital
Seoul, 137-701
About this study
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
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
Read the 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.
- Conditions
- IgA Nephropathy
- Being tested
- Omega-3 fatty acid ethylester90
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 fatty acid ethylester90Drug
Also called Omacor®
Dosage form :1g soft capsule Dosage : two capsules, twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Omacor | Experimental | Not described Receives: Drug: Omega-3 fatty acid ethylester90 |
| Placebo Omacor | Placebo comparator | Not described Receives: Drug: Omega-3 fatty acid ethylester90 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of number of patients that 50% or more increase in SCr after 42 months
Measured: 42 months
Secondary outcomes (2)
The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months
Measured: 42 months
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile
Measured: 42 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pronova BioPharma ASA
- Responsible party
- Sponsor
- Investigators
- Suhnggwon Kim, Professor, Study chair, Seoul National University HospitalByung-Joo Park, MD,PhD,FISPE, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00549692
- Sponsor's protocol ID
- 06-OM-8301
- Acronym
- IgAN
- Status last verified
- Sep 2012
- First submitted
- 25 Oct 2007
- Last updated
- 27 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00549692
- Acronym / sponsor ID
- IgAN / 06-OM-8301
- Conditions
- IgA Nephropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Kuhnil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Pronova BioPharma ASA
- Study start
- Nov 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omacor | Experimental | Drug: Omega-3 fatty acid ethylester90 |
| Placebo Omacor | Placebo comparator | Drug: Omega-3 fatty acid ethylester90 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 fatty acid ethylester90Also: Omacor®Dosage form :1g soft capsule Dosage : two capsules, twice a day. | Drug | Omacor, Placebo Omacor |
Primary outcome
The rate of number of patients that 50% or more increase in SCr after 42 months
Time frame: 42 months
2 secondary outcomes
The rate of number of patients that 50% or more increase in SCr after 6, 12, 24 and 36 months
Time frame: 42 months
Mean change of SCr, estimated GFR, urine Protein/Creatinine ratio, urine Albumin/Creatinine ratio, serum Cystatin C, Lipid profile
Time frame: 42 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2012.
Related trials for IgA Nephropathy
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Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhnggwon Kim, Professor study chair
Seoul National University Hospital
Byung-Joo Park, MD,PhD,FISPE principal investigator
Seoul National University College of Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omega-3 fatty acid ethylester90 in people with IgA Nephropathy, run by Kuhnil Pharmaceutical Co., Ltd. at 5 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of number of patients that 50% or more increase in SCr after 42 months (time frame: 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2012.