HemodialysisCELL-ACT-MEMBRNCT07682701
Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over Trial
A study testing Use of a polysulfone membrane, Use of an asymmetric triacetate membrane and Use of a polymethyl methacrylate membrane in people with Hemodialysis and End Stage Renal Disease (ESRD), run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, End Stage Renal Disease (ESRD), Hemodialysis Treatment
- What is being tested?
- Use of a polysulfone membrane, Use of an asymmetric triacetate membrane and Use of a polymethyl methacrylate membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 13 Apr 2026to 30 Oct 2026
- Phase
- Interventional
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
- Dialysis vintage ≥ 3 months
- Treatment schedule of 3x4 hours weekly
- well functioning dual lumen vascular access
- Treatment with ASA 80-100mg daily
- Patients able and agree to provide signed informed consent
Who cannot join
- Known vascular access dysfunction defined by FOR CATHETER ACCESS: high dose urokinase use within 4 weeks prior to study participation, planned catheter opacification, Qb <250mL/min within the 2 weeks prior to study participation FOR AV ACCESS: planned AV access intervention, recent AV access intervention within 4 weeks prior to study participation, known AV access dysfunction
- Known active malignancy and/or active autoimmune disease
- Known clotting/bleeding disorders
- Current treatment with immunosuppressive medication
- Current treatment with P2Y12 receptor antagonists (including clopidogrel, prasugrel, ticlodipine, cangrelor, ticagrelor), epoprostenol and glycoproteine IIb/IIIa receptor antagonists (tirofiban)
- Current treatment with oral anticoagulation maintenance therapy, including vitamin K antagonists or direct oral anticoagulants
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- Current treatment with low molecular weight heparins (LMWH), heparinoids, bivalirudin, fondaparinux, protein C, or antithrombin.
- Active infection and/or ongoing systemic antimicrobial treatment.
- Hospitalized patients
- Patients treated with heparin-free hemodialysis
- Recent (<1 week) platelet transfusion or packed cells transfusion
- Patients receiving intradialytic TPN
- Patients requiring intravenous iron administration during dialysis (EPO or Parsabiv administration will be postponed until after disconnection from the dialysis circuit and after T240 blood sampling).
- Patients with cytopenia affecting either white blood cells (WBC < 4x10³/mm³) or platelets defined as (platelet counts <100x10³/mm³)
- Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EXPLORING THE MODULATORY EFFECT OF THE DIALYZER MEMBRANE CHOICE ON HEMODIALYSIS ASSOCIATED THROMBOINFLAMMATION: A PROSPECTIVE RANDOMIZED CROSSOVER TRIAL
This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses.
During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week.
Read more
During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells.
The study aims to:
- Assess whether the dialyzer membrane influences leukocyte and platelet activation .
- Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation.
- Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.
- Being tested
- Use of a polysulfone membrane, Use of an asymmetric triacetate membrane, Use of a polymethyl methacrylate membrane
- Keywords
- hemodialysis, thromboinflammation, dialyzer membrane, neutrophil extracellular traps, thrombin generation
- Medical subject headings
- Kidney Failure, Chronic, Thromboinflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of a polysulfone membraneDevice
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)
Use of an asymmetric triacetate membraneDevice
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)
Use of a polymethyl methacrylate membraneDevice
Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)
| Study group | Role | What they receive |
|---|---|---|
| Polysulfone dialyzer membrane | Active comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun) Receives: Device: Use of a polysulfone membrane |
| Asymmetric triacetate dialyzer membrane | Active comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro) Receives: Device: Use of an asymmetric triacetate membrane |
| Polymethyl methacrylate dialyzer membrane | Active comparator | Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray) Receives: Device: Use of a polymethyl methacrylate membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
The primary endpoint will be the difference in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialyzer membrane used.
Measured: Over the course of 1 week (3 hemodialysis sessions)
Secondary outcomes (3)
Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition
differences in leukocyte and platelet activation markers in blood samples and rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition; assessed by mean fluorescence intensity and the relative number of positive cells for the respective activation marker measured by flow cytometry.
Measured: over the course of 1 week (3 hemodialysis sessions)
Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition
Biological evaluation of systemic coagulation activation and inflammation in relation to dialysate composition. Markers will be measured using multiplex-based immunoassays from plasma samples collected.
Measured: Over the course of 1 week (3 hemodialysis sessions)
Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition
Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.
Measured: Over the course of 1 week (3 hemodialysis sessions)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2026
- Study start13 Apr 2026
- Primary completion15 May 2026
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study uses a prospective, randomized, crossover design during which biological samples will be collected during each treatment session (3 in total over the course of 1 week). During each session, the patient will be treated by another dialyzer membrane (polysulphone vs asymmetric triacetate vs polymethyl methacrylate)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Vrije Universiteit Brussel, NIER research group, University of Rochester
- Responsible party
- Sponsor
- Investigators
- Florine Janssens, Medical Doctor, Principal investigator, Universitair Ziekenhuis Brussel (UZ Brussel)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07682701
- Sponsor's protocol ID
- BUN 1432026000041
- Acronym
- CELL-ACT-MEMBR
- Status last verified
- May 2026
- First submitted
- 26 Jun 2026
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided