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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-05

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemodialysis Thromboinflammation Hemodialysis Complication End Stage Renal Disease (ESRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

This study focuses on the additional collection of biological samples during the pilot OMAGOD trial. The original study design-a prospective, randomized, single-blind, parallel-group crossover study-will remain unchanged other than the collection of additional samples. Sample collection for this study will be conducted exclusively at our center and will take place during the last hemodialysis session of each treatment period (3 HD sessions per participant).

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Acetic acid dialysate (0.5 mmol/L Mg)

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) during which patients will be dialyzed with standard acetate-based dialysate containing 0,5 mmol/L magnesium.

Group Type ACTIVE_COMPARATOR

Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Intervention Type OTHER

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

Citric acid dialysate (Mg 1.0 mmol/L)

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citric acid dialysate containing magnesium 1.0 mmol/L

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Citric acid dialysate (Mg 0.75 mmol/L)

Standardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citrate-enriched dialysate containing magnesium 0.75 mmol/L

Group Type ACTIVE_COMPARATOR

Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants to the OMAGOD pilot trial

Exclusion Criteria

* Patients who are not participating in the OMAGOD pilot trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florine Janssens, Medical doctor

Role: PRINCIPAL_INVESTIGATOR

(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)