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

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.

Conditions

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

Interventions

DEVICE

Use of a polysulfone membrane

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

DEVICE

Use of an asymmetric triacetate membrane

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

DEVICE

Use of a polymethyl methacrylate membrane

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

Sponsors & Collaborators

• Vrije Universiteit Brussel

  collaborator OTHER

• NIER research group

  collaborator UNKNOWN

• University of Rochester

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

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

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-13

Primary Completion

2026-05-15

Completion

2026-10-30

Countries

• Belgium

Study Locations