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NCT Number: NCT07206524

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

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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Key information

Conditions

Hemodialysis Blood Coagulation Disorders Cardiovascular Diseases Chronic Disease Disease Attributes Embolism and Thrombosis End Stage Renal Disease (ESRD) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemodialysis Complication Inflammation Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Thromboinflammation Thrombosis Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants to the OMAGOD pilot trial

Exclusion criteria

  • Patients who are not participating in the OMAGOD pilot trial

Treatment and study plan

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

Other

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

Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Other

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

Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L

Other

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

Primary outcomes

  1. Differences in leukocyte counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition

    Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)

    The primary endpoint will be the difference in leukocyte counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition (acetic acid vs. citric acid Mg 0.75 mmol/L vs. citric acid 1.0 mmol/L)

Secondary outcomes

  1. differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition

    Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)

    differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition, evaluated by hematologic cell analyzer

  2. 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

    Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)

    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.

  3. Differences in coagulation activation and inflammatory biomarkers measured by multiplex-based immunoassays in relation to dialysate composition

    Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)

    Biological evaluation of systemic coagulation activation and inflammation in relation to dialysate composition. Biomarkers will be measured using multiplex-based immunoassays from plasma samples collected during midweek dialysis sessions.

  4. Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition

    Time frame: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)

    Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.

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Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • University of Rochester
  • Vrije Universiteit Brussel

Registry information

Official study title

Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial

Acronym: pilot OMAGOD +

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 3, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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