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Active, not recruitingNCT07682701CELL-ACT-MEMBRUpdated Jul 6, 2026

Exploring the Modulatory Effect of the Dialyzer Membrane Choice on Hemodialysisassociated Thromboinflammation: a Prospective Randomized Cross-over Trial

An interventional study of Use of a polysulfone membrane and Use of an asymmetric triacetate membrane in Hemodialysis, End Stage Renal Disease (ESRD) and Hemodialysis Treatment, sponsored by Universitair Ziekenhuis Brussel. Active, not recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

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.
02

Conditions studied

  • Hemodialysis
  • End Stage Renal Disease (ESRD)
  • Hemodialysis Treatment
  • Thromboinflammation

Keywords

  • hemodialysis
  • thromboinflammation
  • dialyzer membrane
  • neutrophil extracellular traps
  • thrombin generation
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 10 is below the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Active comparator
    Polysulfone dialyzer membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)

    Device: Use of a polysulfone membrane

  • Active comparator
    Asymmetric triacetate dialyzer membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)

    Device: Use of an asymmetric triacetate membrane

  • Active comparator
    Polymethyl methacrylate dialyzer membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

    Device: Use of a polymethyl methacrylate membrane

Interventions

  • DeviceUse of a polysulfone membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Xevonta, Braun)

  • DeviceUse of an asymmetric triacetate membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Solacea, Nipro)

  • DeviceUse of a polymethyl methacrylate membrane

    Standardized hemodialysis treatments 3x4hours/week. Intervention: use of a polysulfone dialyzer membrane (Filtryzer, Toray)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Over the course of 1 week (3 hemodialysis sessions)

Secondary outcomes

  1. 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.

    Time frame: over the course of 1 week (3 hemodialysis sessions)

  2. 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.

    Time frame: Over the course of 1 week (3 hemodialysis sessions)

  3. 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.

    Time frame: Over the course of 1 week (3 hemodialysis sessions)

07

Study locations

1 site
  • Universitair Ziekenhuis Brussel
    Brussels, 1090, Belgium
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07682701
Lead sponsor
Universitair Ziekenhuis Brussel
Collaborators
Vrije Universiteit Brussel, NIER research group, University of Rochester
Responsible party
Sponsor
First posted
Jul 6, 2026
Start date
Apr 13, 2026
Primary completion
May 15, 2026
Completion
Oct 30, 2026 (estimated)
Last update
Jul 6, 2026

Study contacts

Florine Janssens, Medical Doctor
principal investigator · Universitair Ziekenhuis Brussel (UZ Brussel)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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