Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation

Summary

This clinical trial investigates whether the composition of dialysate influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of magnesium concentration and acid type in dialysate on immune cell activation and thromboinflammatory responses.

Patients participating to the multicentric pilot OMAGOD trial will be invited to participate to this monocentric plus study.

In the pilot OMAGOD trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialysate compositions in a crossover design. Each treatment phase lasts two weeks (six sessions).

For the local plus study, during selected sessions (3 per patient - midweek hemodialysis session of the last week of a treatment period), 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 dialysate composition influences leukocyte and platelet activation .
* Evaluate whether the dialysate composition influences neutrophil extracellular trap (NET) formation.
* Identify novel biomarkers of thromboinflammation using transcriptomic analysis of immune cells.

Conditions

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

Interventions

OTHER

Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Standard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions.

OTHER

Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L

Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.

OTHER

Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L

Change dialysate compositions being used during hemodialysis treatment in each arm.

Sponsors & Collaborators

• University of Rochester

  collaborator OTHER

• Vrije Universiteit Brussel, Jette, Belgium

  collaborator UNKNOWN

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

• Florine Janssens, Medical doctor · (1)Department of Nephrology and Arterial Hypertension, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium. (2) Kidney diseases, dialysis & transplantation Research Unit (NIER), Vitality Research Group, Vrije Universiteit Brussel (VUB)

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-05

Primary Completion

2025-11-30

Completion

2026-12-31

Countries

• Belgium

Study Locations