End Stage Renal Disease on DialysisNCT06526702
Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
A study testing High-flux hemodialysis and Post-dilution hemodiafiltration in people with End Stage Renal Disease on Dialysis, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This randomized, crossover study aims to investigate the intradialytic kinetics of selected cardiac biomarkers in patients with end-stage renal disease treated with dialysis. The cardiac biomarkers of interest include high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease on Dialysis
- What is being tested?
- High-flux hemodialysis and Post-dilution hemodiafiltration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Sep 2024to 10 Apr 2025
- Phase
- Interventional
- 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
- Age of 18 years or older.
- Clinically stable patients with end-stage renal disease treated with maintenance hemodialysis or peritoneal dialysis.
- Regarding patients treated with hemodialysis: Dialysis access with an arteriovenous fistula and able to maintain a blood flow rate >300 mL.
Who cannot join
- Not able to understand or sign informed consent.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nephrology, Aalborg University Hospital
Aalborg, 9000
About this study
This randomized, crossover study aims to investigate the intradialytic kinetics of selected cardiac biomarkers in patients with end-stage renal disease treated with dialysis. The cardiac biomarkers of interest include high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and a novel cardiac biomarker named secretoneurin.
In 24 patients treated with maintenance hemodialysis, the study will compare high-flux hemodialysis (HD) with post-dilution hemodiafiltration (HDF) to investigate:
Read more
- Baseline concentrations and week-to-week plasma variations of the cardiac biomarkers.
- Changes in the plasma concentrations of the cardiac biomarkers during high-flux HD and post-dilution HDF.
- Dialyzer clearance of the cardiac biomarkers in high-flux HD and post-dilution HDF.
- Adherence of the cardiac biomarkers to the dialyzer membrane.
- Concentrations of the cardiac biomarkers 30 minutes post-dialysis to investigate a potential rebound effect.
Additionally, a sub-study of 24 patients treated with peritoneal dialysis will investigate the baseline concentrations and week-to-week plasma variations of the same cardiac biomarkers.
Read the detailed description
Patients treated with maintenance hemodialysis:
Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux HD (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.
On both trial days, the following dialysis settings will be the same for each individual patient:
- The dialysis sessions will last 4 hours.
- The same dialysis machine will be used, either the Fresenius Medical Care 5008 or 6008 CAREsystem machine.
- Same vascular access will be used.
- The composition of electrolytes in the dialysate will be the same.
- Blood flow rate will be >300 mL per minute and consistent.
- Dialysate flow rate will be 500 mL per minute.
- Ultrafiltration rate will be constant aiming at dry weight.
- Routine anticoagulation protocol will be unchanged, but consistent on both trial days.
- Routine dialysate temperature will be unchanged, but consistent on both trial days.
On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples. Blood samples, for the analysis of the selected cardiac biomarkers, will be collected:
- Before the dialysis session is started (baseline).
- After 10, 30, 60, 120, 180, and 240 minutes of dialysis. All samples will be collected from the blood dialyzer inlet; however, halfway into the dialysis session (after 120 minutes), samples will also be collected from the blood dialyzer outlet and from the dialysate.
- 30 minutes after dialysis cessation. However, if the patient will not stay 30 minutes, the post-dialysis sample will be gathered after 5 minutes.
Sub-study of patients treated with peritoneal dialysis:
In a sub-study, 24 patients treated with peritoneal dialysis, will be included for one or two venous blood samples (with a minimum of 1 week between) to determine the baseline concentration and week-to-week variation of the cardiac biomarkers of interest. On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples.
- Conditions
- End Stage Renal Disease on Dialysis
- Being tested
- High-flux hemodialysis, Post-dilution hemodiafiltration
- Keywords
- Renal Dialysis, Hemodiafiltration, Hemodialysis, Peritoneal Dialysis, Renal Replacement Therapy, Troponin, Natriuretic Peptide, Brain, Secretoneurin, Biomarkers, Cardiovascular Diseases
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-flux hemodialysisDevice
FX CorDiax 100 dialyzer
Post-dilution hemodiafiltrationDevice
FX CorDiax 1000 dialyzer
| Study group | Role | What they receive |
|---|---|---|
| High-flux hemodialysis then post-dilution hemodiafiltration | Experimental | Participants will first receive high-flux hemodialysis. Following a washout period of 1-3 weeks, they will receive post-dilution hemodiafiltration. Receives: Device: High-flux hemodialysis; Device: Post-dilution hemodiafiltration |
| Post-dilution hemodiafiltration then high-flux hemodialysis | Experimental | Participants will first receive post-dilution hemodiafiltration. Following a washout period of 1-3 weeks, they will receive high-flux hemodialysis. Receives: Device: High-flux hemodialysis; Device: Post-dilution hemodiafiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration.
Changes in the selected cardiac biomarkers from baseline, to after 10, 30, 60, 120, 180, and 240 minutes of dialysis, and 5-30 min. after dialysis cessation in both high-flux hemodialysis and post-dilution hemodiafiltration. The two dialysis modalities will be compared.
Measured: Before the start of a dialysis session; after 10, 30, 60, 120, 180, and 240 minutes of dialysis; and 5-30 min. after dialysis cessation.
Secondary outcomes (2)
Dialyzer clearance of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltration.
Dialyzer clearance, calculated by dialysate and blood after 120 minutes of dialysis, of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltation. The two dialysis modalities will be compared.
Measured: After 120 minutes of dialysis.
Adherence of the cardiac biomarkers to the dialyzer membrane in high-flux hemodialysis and post-dilution hemodiafiltration.
Adherence of the cardiac biomarkers to the dialyzer membrane after 120 minutes of dialysis in high-flux hemodialysis and post-dilution hemodiafiltation. The two dialysis modalities will be compared.
Measured: After 120 minutes of dialysis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start12 Sep 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Disease on DialysisStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux hemodialysis (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline Hundborg Liboriussen, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526702
- Sponsor's protocol ID
- F2024-045 and N-20240016
- Status last verified
- Oct 2025
- First submitted
- 24 Jul 2024
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Drivsholm CL, Nygaard L, Dam-Dalgeir G, Glerup RI, Birnum A, Jensen JD, Svensson M. Intradialytic Kinetics of Cardiac Biomarkers during High-Flux Hemodialysis and Postdilution Hemodiafiltration: A Randomized Crossover Trial. Kidney360. 2026 Oct 1;7(10):2291-2302. doi: 10.34067/KID.0000001284. Epub 2026 Jul 20.
PubMed 42475358Drivsholm CL, Nygaard L, Glerup RI, Birnum ATS, Jensen JD, Svensson M. Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial. BMJ Open. 2026 Jan 16;16(1):e105551. doi: 10.1136/bmjopen-2025-105551.
PubMed 41545041
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intradialytic Kinetics of Cardiac Biomarkers During Hemodialysis and Hemodiafiltration
- ClinicalTrials.gov ID
- NCT06526702
- Acronym / sponsor ID
- F2024-045 and N-20240016
- Conditions
- End Stage Renal Disease on Dialysis
- Keywords
- Renal Dialysis, Hemodiafiltration, Hemodialysis, Peritoneal Dialysis, Renal Replacement Therapy, Troponin, Natriuretic Peptide, Brain, Secretoneurin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 30 Jul 2024 (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.
This randomized, crossover study aims to investigate the intradialytic kinetics of selected cardiac biomarkers in patients with end-stage renal disease treated with dialysis. The cardiac biomarkers of interest include high-sensitivity cardiac troponin I, high-sensitivity cardiac troponin T, brain natriuretic peptide, and a novel cardiac biomarker named secretoneurin.
In 24 patients treated with maintenance hemodialysis, the study will compare high-flux hemodialysis (HD) with post-dilution hemodiafiltration (HDF) to investigate:
- Baseline concentrations and week-to-week plasma variations of the cardiac biomarkers.
- Changes in the plasma concentrations of the cardiac biomarkers during high-flux HD and post-dilution HDF.
- Dialyzer clearance of the cardiac biomarkers in high-flux HD and post-dilution HDF.
- Adherence of the cardiac biomarkers to the dialyzer membrane.
- Concentrations of the cardiac biomarkers 30 minutes post-dialysis to investigate a potential rebound effect.
Additionally, a sub-study of 24 patients treated with peritoneal dialysis will investigate the baseline concentrations and week-to-week plasma variations of the same cardiac biomarkers.
Detailed description
Patients treated with maintenance hemodialysis:
Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux HD (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.
On both trial days, the following dialysis settings will be the same for each individual patient:
- The dialysis sessions will last 4 hours.
- The same dialysis machine will be used, either the Fresenius Medical Care 5008 or 6008 CAREsystem machine.
- Same vascular access will be used.
- The composition of electrolytes in the dialysate will be the same.
- Blood flow rate will be >300 mL per minute and consistent.
- Dialysate flow rate will be 500 mL per minute.
- Ultrafiltration rate will be constant aiming at dry weight.
- Routine anticoagulation protocol will be unchanged, but consistent on both trial days.
- Routine dialysate temperature will be unchanged, but consistent on both trial days.
On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples. Blood samples, for the analysis of the selected cardiac biomarkers, will be collected:
- Before the dialysis session is started (baseline).
- After 10, 30, 60, 120, 180, and 240 minutes of dialysis. All samples will be collected from the blood dialyzer inlet; however, halfway into the dialysis session (after 120 minutes), samples will also be collected from the blood dialyzer outlet and from the dialysate.
- 30 minutes after dialysis cessation. However, if the patient will not stay 30 minutes, the post-dialysis sample will be gathered after 5 minutes.
Sub-study of patients treated with peritoneal dialysis:
In a sub-study, 24 patients treated with peritoneal dialysis, will be included for one or two venous blood samples (with a minimum of 1 week between) to determine the baseline concentration and week-to-week variation of the cardiac biomarkers of interest. On both trial days, different baseline characteristics will be gathered, including demographic data, clinical data, dialysis characteristics, and routine blood samples.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, randomized, crossover study with 24 participants. The study will investigate the effect of high-flux hemodialysis (using the FX CorDiax 100 dialyzer) and post-dilution HDF (using the FX CorDiax 1000 dialyzer) on the intradialytic kinetics of selected cardiac biomarkers. The study will not be blinded, but the order of the interventions will be randomized. The two dialysis sessions will be conducted on the same weekday. Between the two interventions, the patient will have a wash-out period of 1-3 weeks with standard dialysis treatment.
| Arm | Type | Receives |
|---|---|---|
| High-flux hemodialysis then post-dilution hemodiafiltration | Experimental | Device: High-flux hemodialysis, Device: Post-dilution hemodiafiltrationParticipants will first receive high-flux hemodialysis. Following a washout period of 1-3 weeks, they will receive post-dilution hemodiafiltration. |
| Post-dilution hemodiafiltration then high-flux hemodialysis | Experimental | Device: High-flux hemodialysis, Device: Post-dilution hemodiafiltrationParticipants will first receive post-dilution hemodiafiltration. Following a washout period of 1-3 weeks, they will receive high-flux hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age of 18 years or older.
- Clinically stable patients with end-stage renal disease treated with maintenance hemodialysis or peritoneal dialysis.
- Regarding patients treated with hemodialysis: Dialysis access with an arteriovenous fistula and able to maintain a blood flow rate >300 mL.
Key exclusion criteria (1 listed)
- Not able to understand or sign informed consent.
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 |
|---|---|---|
| High-flux hemodialysisFX CorDiax 100 dialyzer | Device | High-flux hemodialysis then post-dilution hemodiafiltration, Post-dilution hemodiafiltration then high-flux hemodialysis |
| Post-dilution hemodiafiltrationFX CorDiax 1000 dialyzer | Device | High-flux hemodialysis then post-dilution hemodiafiltration, Post-dilution hemodiafiltration then high-flux hemodialysis |
Primary outcome
Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration.
Time frame: Before the start of a dialysis session; after 10, 30, 60, 120, 180, and 240 minutes of dialysis; and 5-30 min. after dialysis cessation.
Changes in the selected cardiac biomarkers from baseline, to after 10, 30, 60, 120, 180, and 240 minutes of dialysis, and 5-30 min. after dialysis cessation in both high-flux hemodialysis and post-dilution hemodiafiltration. The two dialysis modalities will be compared.
2 secondary outcomes
Dialyzer clearance of the cardiac biomarkers in high-flux hemodialysis and post-dilution hemodiafiltration.
Time frame: After 120 minutes of dialysis.
Adherence of the cardiac biomarkers to the dialyzer membrane in high-flux hemodialysis and post-dilution hemodiafiltration.
Time frame: After 120 minutes of dialysis.
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 7 Oct 2025.
- Derived from this study: PubMed 42475358Drivsholm CL, Nygaard L, Dam-Dalgeir G, Glerup RI, Birnum A, Jensen JD, Svensson M. Intradialytic Kinetics of Cardiac Biomarkers during High-Flux Hemodialysis and Postdilution Hemodiafiltration: A Randomized Crossover Trial. Kidney360. 2026 Oct 1;7(10):2291-2302. doi: 10.34067/KID.0000001284. Epub 2026 Jul 20.
- Derived from this study: PubMed 41545041Drivsholm CL, Nygaard L, Glerup RI, Birnum ATS, Jensen JD, Svensson M. Intradialytic kinetics of cardiac biomarkers during high-flux haemodialysis and postdilution haemodiafiltration: study protocol for a randomised crossover trial. BMJ Open. 2026 Jan 16;16(1):e105551. doi: 10.1136/bmjopen-2025-105551.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-flux hemodialysis and Post-dilution hemodiafiltration in people with End Stage Renal Disease on Dialysis, run by Aalborg University Hospital 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 3 inclusion and 1 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 7 Oct 2025. 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.
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?
Changes in the cardiac biomarkers from baseline to during and after high-flux hemodialysis and post-dilution hemodiafiltration. (time frame: Before the start of a dialysis session; after 10, 30, 60, 120, 180, and 240 minutes of dialysis; and 5-30 min. after dialysis cessation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06526702, which also lists 2 linked publications.
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 7 Oct 2025.