Kidney Failure ChronicEFFLUX-HDNCT07730385
Fish Oil and HDL Function in Patients on Maintenance Hemodialysis
A study testing n-3 PUFA (fish oil) in people with Kidney Failure Chronic and Cardiovascular Disease, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure Chronic, Cardiovascular Disease, HDL Cholesterol
- What is being tested?
- n-3 PUFA (fish oil)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- age ≥ 18 years
- receiving maintenance in-center hemodialysis
- able to provide written informed consent
- clinically stable condition (no hospitalization within 4 weeks prior to baseline)
Who cannot join
- inability or unwillingness to provide informed consent
- known hypersensitivity or intolerance to fish oil or n-3 PUFA-containing products
- use of n-3 PUFA supplements at baseline or within the preceding 8 weeks
- pregnancy
- acute infection, hospitalization or major inflammatory condition at the time of baseline assessment
- any condition that, in the investigator's opinion, would make participation unsafe or interfere with study participation or data interpretation
- inherited lipid metabolism disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Janosch Niknam-Saeidi, MD contact
Manfred Hecking, MD, PhD contact
Austria1 site
Chronic Hemodialysis Unit, Division of Nephrology and Dialysis, Department of Medicine III, Medical University of Vienna
Vienna, State of Vienna, 1090
Janosch Niknam-Saeidi, MD, janosch.niknamsaeidi@meduniwien.ac.at
Janosch Niknam-Saeidi, MD
About this study
Official title: Mechanistic Effects of n-3 Polyunsaturated Fatty Acid Supplementation on HDL Function in Patients Receiving Maintenance Hemodialysis (EFFLUX-HD): Study Protocol for a Randomized, Open-label, Crossover Trial
Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. A recent clinical trial (PISCES) found that high-dose omega-3 fatty acids (fish oil) reduced cardiovascular events in hemodialysis patients, but the reason for this benefit is not understood.
One possible explanation is that, in kidney failure, high-density lipoprotein (HDL) no longer works normally. This study investigates whether omega-3 fatty acid supplementation improves the function of HDL in people on maintenance hemodialysis.
Read more
Forty adults on maintenance hemodialysis will take part. Each participant receives fish oil (4 g per day) for 8 weeks and also has an 8-week period without supplementation; participants are randomly assigned to the order of these two periods (crossover design), for a total of 16 weeks each. The main measure is cholesterol efflux capacity, a laboratory test of how well HDL removes cholesterol from cells. The study also examines other markers of HDL quality.
This is an exploratory, mechanistic study. Its aim is to determine whether omega-3 fatty acids change HDL function and to inform the design of larger future trials.
Read the detailed description
Patients receiving maintenance hemodialysis (HD) experience exceptionally high cardiovascular (CV) mortality that is not adequately addressed by conventional lipid-lowering strategies. The PISCES trial demonstrated that high-dose n-3 polyunsaturated fatty acid (n-3 PUFA) supplementation reduces CV events in HD patients, yet the underlying mechanism remains unknown.
In the uremic milieu, HDL undergoes qualitative changes-including enrichment with serum amyloid A (SAA), loss of anti-oxidative capacity, and impaired cholesterol efflux capacity (CEC)-that render it dysfunctional and may contribute to CV risk independently of HDL cholesterol concentration. Evidence from non-dialysis populations suggests that n-3 PUFA can favorably modify the HDL proteome and improve HDL function. The investigators hypothesize that n-3 PUFA supplementation favorably modulates HDL function in HD patients, which could help explain the CV benefit observed in PISCES.
EFFLUX-HD is a single-center, prospective, randomized, open-label, crossover, exploratory mechanistic study conducted at the Chronic Hemodialysis Unit of the Vienna General Hospital (Medical University of Vienna). Forty adults on maintenance HD are randomized 1:1 to one of two treatment sequences that differ in the order of an 8-week n-3 PUFA supplementation period (4 g/day fish oil; approximately 1.6 g EPA and 0.8 g DHA, matching the PISCES dose) and an 8-week off-treatment period, without a formal washout, for a total of 16 weeks per participant. The crossover design allows each participant to serve as their own control, removing the substantial between-participant variability in HDL functional measures.
Outcomes are analyzed using linear mixed-effects models. No formal sample-size calculation was performed given the exploratory, mechanistic design; the target of 40 participants is intended to estimate within-participant effects and the variability of HDL functional parameters to inform future confirmatory trials. The study was approved by the Ethics Committee of the Medical University of Vienna and is conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice.
- Being tested
- n-3 PUFA (fish oil)
- Medical subject headings
- Renal Insufficiency, Chronic, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
n-3 PUFA (fish oil)Dietary supplement
4g/day fish oil (four 1 g capsules) providing approximately 1.6 g EPA and 0.8 g DHA, taken for 8 weeks, matching the PISCES dose
| Study group | Role | What they receive |
|---|---|---|
| Group A: n-3 PUFA then off-treatment | Experimental | Participants receive n-3 PUFA supplementation (4 g/day fish oil) for 8 weeks, followed by an 8-week off-treatment period. Receives: Dietary Supplement: n-3 PUFA (fish oil) |
| Group B: off-treatment then n-3 PUFA | Experimental | Participants undergo an 8-week off-treatment period, followed by 8 weeks of n-3 PUFA supplementation (4 g/day fish oil). Receives: Dietary Supplement: n-3 PUFA (fish oil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol Efflux Capacity (CEC)
Cholesterol efflux capacity of apolipoprotein B-depleted serum, measured with a cell-based fluorescent assay and reported as percentage cholesterol efflux (%).
Measured: Weeks 1, 8, and 16
Secondary outcomes (2)
Serum Amyloid A (SAA)
Serum amyloid A concentration in serum, obtained from routine clinical laboratory measurement and reported in mg/L.
Measured: Weeks 1, 8, and 16
Biologically Effective HDL
Biologically effective HDL, calculated from concomitantly measured HDL cholesterol and serum amyloid A concentrations and reported in mg/dL.
Measured: Weeks 1, 8, and 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two-sequence crossover: participants are randomized 1:1 to receive 8 weeks of n-3 PUFA supplementation followed by an 8-week off-treatment period (sequence A), or the reverse order (sequence B). No formal washout period is interposed; total duration is 16 weeks per participant
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Manfred Hecking, MD PhD, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730385
- Sponsor's protocol ID
- EK Nr: 1072/202 (EFFLUX-HD)
- Acronym
- EFFLUX-HD
- Status last verified
- Aug 2026
- First submitted
- 19 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Effects of n-3 Polyunsaturated Fatty Acid Supplementation on HDL Function in Patients Receiving Maintenance Hemodialysis (EFFLUX-HD): Study Protocol for a Randomized, Open-label, Crossover Trial
- ClinicalTrials.gov ID
- NCT07730385
- Acronym / sponsor ID
- EFFLUX-HD / EK Nr: 1072/202 (EFFLUX-HD)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Jul 2026 (actual)
- 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.
Patients who receive maintenance hemodialysis have a very high risk of cardiovascular disease, and standard cholesterol-lowering treatments such as statins have not been shown to reduce cardiovascular events in this group. A recent clinical trial (PISCES) found that high-dose omega-3 fatty acids (fish oil) reduced cardiovascular events in hemodialysis patients, but the reason for this benefit is not understood.
One possible explanation is that, in kidney failure, high-density lipoprotein (HDL) no longer works normally. This study investigates whether omega-3 fatty acid supplementation improves the function of HDL in people on maintenance hemodialysis.
Forty adults on maintenance hemodialysis will take part. Each participant receives fish oil (4 g per day) for 8 weeks and also has an 8-week period without supplementation; participants are randomly assigned to the order of these two periods (crossover design), for a total of 16 weeks each. The main measure is cholesterol efflux capacity, a laboratory test of how well HDL removes cholesterol from cells. The study also examines other markers of HDL quality.
This is an exploratory, mechanistic study. Its aim is to determine whether omega-3 fatty acids change HDL function and to inform the design of larger future trials.
Detailed description
Patients receiving maintenance hemodialysis (HD) experience exceptionally high cardiovascular (CV) mortality that is not adequately addressed by conventional lipid-lowering strategies. The PISCES trial demonstrated that high-dose n-3 polyunsaturated fatty acid (n-3 PUFA) supplementation reduces CV events in HD patients, yet the underlying mechanism remains unknown.
In the uremic milieu, HDL undergoes qualitative changes-including enrichment with serum amyloid A (SAA), loss of anti-oxidative capacity, and impaired cholesterol efflux capacity (CEC)-that render it dysfunctional and may contribute to CV risk independently of HDL cholesterol concentration. Evidence from non-dialysis populations suggests that n-3 PUFA can favorably modify the HDL proteome and improve HDL function. The investigators hypothesize that n-3 PUFA supplementation favorably modulates HDL function in HD patients, which could help explain the CV benefit observed in PISCES.
EFFLUX-HD is a single-center, prospective, randomized, open-label, crossover, exploratory mechanistic study conducted at the Chronic Hemodialysis Unit of the Vienna General Hospital (Medical University of Vienna). Forty adults on maintenance HD are randomized 1:1 to one of two treatment sequences that differ in the order of an 8-week n-3 PUFA supplementation period (4 g/day fish oil; approximately 1.6 g EPA and 0.8 g DHA, matching the PISCES dose) and an 8-week off-treatment period, without a formal washout, for a total of 16 weeks per participant. The crossover design allows each participant to serve as their own control, removing the substantial between-participant variability in HDL functional measures.
Outcomes are analyzed using linear mixed-effects models. No formal sample-size calculation was performed given the exploratory, mechanistic design; the target of 40 participants is intended to estimate within-participant effects and the variability of HDL functional parameters to inform future confirmatory trials. The study was approved by the Ethics Committee of the Medical University of Vienna and is conducted in accordance with the Declaration of Helsinki and the principles of Good Clinical Practice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-sequence crossover: participants are randomized 1:1 to receive 8 weeks of n-3 PUFA supplementation followed by an 8-week off-treatment period (sequence A), or the reverse order (sequence B). No formal washout period is interposed; total duration is 16 weeks per participant
| Arm | Type | Receives |
|---|---|---|
| Group A: n-3 PUFA then off-treatment | Experimental | Dietary Supplement: n-3 PUFA (fish oil)Participants receive n-3 PUFA supplementation (4 g/day fish oil) for 8 weeks, followed by an 8-week off-treatment period. |
| Group B: off-treatment then n-3 PUFA | Experimental | Dietary Supplement: n-3 PUFA (fish oil)Participants undergo an 8-week off-treatment period, followed by 8 weeks of n-3 PUFA supplementation (4 g/day fish oil). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- receiving maintenance in-center hemodialysis
- able to provide written informed consent
- clinically stable condition (no hospitalization within 4 weeks prior to baseline)
Key exclusion criteria (7 listed)
- inability or unwillingness to provide informed consent
- known hypersensitivity or intolerance to fish oil or n-3 PUFA-containing products
- use of n-3 PUFA supplements at baseline or within the preceding 8 weeks
- pregnancy
- acute infection, hospitalization or major inflammatory condition at the time of baseline assessment
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 |
|---|---|---|
| n-3 PUFA (fish oil)4g/day fish oil (four 1 g capsules) providing approximately 1.6 g EPA and 0.8 g DHA, taken for 8 weeks, matching the PISCES dose | Dietary supplement | Group A: n-3 PUFA then off-treatment, Group B: off-treatment then n-3 PUFA |
Primary outcome
Cholesterol Efflux Capacity (CEC)
Time frame: Weeks 1, 8, and 16
Cholesterol efflux capacity of apolipoprotein B-depleted serum, measured with a cell-based fluorescent assay and reported as percentage cholesterol efflux (%).
2 secondary outcomes
Serum Amyloid A (SAA)
Time frame: Weeks 1, 8, and 16
Biologically Effective HDL
Time frame: Weeks 1, 8, and 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Janosch Niknam-Saeidi, MD contact
Manfred Hecking, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing n-3 PUFA (fish oil) in people with Kidney Failure Chronic and Cardiovascular Disease, run by Medical University of Vienna at 1 site in Austria.
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 7 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: opening soon, as of the sponsor's last update on 4 Aug 2026. 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 Austria. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janosch Niknam-Saeidi, MD (janosch.niknamsaeidi@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol Efflux Capacity (CEC) (time frame: Weeks 1, 8, and 16). 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 4 Aug 2026.