Kidney Failure, ChronicPhase 4NCT00257283
Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
A Phase 4 study testing Omega-3-acid ethyl esters 90 in people with Kidney Failure, Chronic, run by Pronova BioPharma at 1 site in Denmark.
Trial summary
The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Omega-3-acid ethyl esters 90
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2002to Jun 2005
- Phase
- Phase 4
- 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
- Males and females above 18 years of age
- Patients having been treated with chronic hemodialysis for at least 6 months
- Patients with documented cardiovascular disease, at least one of the following
- Angina pectoris
- Previous Acute myocardial infarction
- Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
Show all 10Show fewer
- Previous Transitory Cerebral Ischemia
- Previous Apoplexia Cerebri
- Symptoms of peripheral vascular disease
- Written informed consent
Who cannot join
- Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
- Patients undergoing peritoneal dialysis
- Any condition associated with a risk of poor compliance, as judged by investigator
- Pregnant or breastfeeding
- Participation in other clinical studies involving treatment with drugs.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital
Aalborg, 9100
About this study
Official title: A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
Read the detailed description
Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
Design: A prospective, randomised, placebo controlled study. 2 year treatment period.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Omega-3-acid ethyl esters 90
- Keywords
- Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3-acid ethyl esters 90Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint, including either of the following events:
- Acute Myocardial Infarction
- Angina Pectoris, leading to coronary investigation or intervention
- Transient Cerebral Ischemia (TCI)
- Apoplexia cerebri (stroke)
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
- Death
Secondary outcomes (5)
- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
- Efficacy, fatty acid profile for phospholipids fraction
- Efficacy: diet registration, fish score
- Thrombosis and/or stenosis of dialysis graft
- Effect on heart rate variability, substudy of 50 patients at baseline and after three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startNov 2002
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- Pronova BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Danish Heart Foundation, The Danish Kidney Association, North Denmark Region
- Investigators
- My Svensson, MD, Principal investigator, Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257283
- Sponsor's protocol ID
- CTN K85 02024
- Status last verified
- Mar 2008
- First submitted
- 21 Nov 2005
- Last updated
- 11 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind Comparison of Omacor and Placebo as Secondary Prevention Against Cardiovascular Events in Patients Undergoing Chronic Hemodialysis
- ClinicalTrials.gov ID
- NCT00257283
- Acronym / sponsor ID
- CTN K85 02024
- Conditions
- Kidney Failure, Chronic
- Keywords
- Chronic renal failure, Hemodialysis, OMACOR (omega-3-acid ethyl ester 90), intervention study, cardiovascular events, mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- Pronova BioPharmaIndustry (pharma, biotech, devices)
- Collaborators
- Danish Heart Foundation, The Danish Kidney Association, North Denmark Region
- Study start
- Nov 2002
- Study completion
- Jun 2005
- First posted
- 22 Nov 2005 (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 aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
Detailed description
Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.
Design: A prospective, randomised, placebo controlled study. 2 year treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males and females above 18 years of age
- Patients having been treated with chronic hemodialysis for at least 6 months
- Patients with documented cardiovascular disease, at least one of the following
- Written informed consent
Key exclusion criteria (5 listed)
- Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
- Patients undergoing peritoneal dialysis
- Any condition associated with a risk of poor compliance, as judged by investigator
- Pregnant or breastfeeding
- Participation in other clinical studies involving treatment with drugs.
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-acid ethyl esters 90 | Drug | – |
Primary outcome
Composite endpoint, including either of the following events:
- Acute Myocardial Infarction
- Angina Pectoris, leading to coronary investigation or intervention
- Transient Cerebral Ischemia (TCI)
- Apoplexia cerebri (stroke)
- Peripheral Vascular disease, new symptoms or worsening of old symptoms
- Death
5 secondary outcomes
- Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
- Efficacy, fatty acid profile for phospholipids fraction
- Efficacy: diet registration, fish score
- Thrombosis and/or stenosis of dialysis graft
- Effect on heart rate variability, substudy of 50 patients at baseline and after three 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 11 Mar 2008.
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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.
My Svensson, MD principal investigator
Department of Nephrology, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Omega-3-acid ethyl esters 90 in people with Kidney Failure, Chronic, run by Pronova BioPharma at 1 site in Denmark.
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 10 inclusion and 5 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 11 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Composite endpoint, including either of the following events:. The study lists 7 primary outcomes in all. 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 11 Mar 2008.