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

NCT07206524 | Recruiting

• 1 other identifier: 25113_PILOTOMAGOD
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

hemodialysis; thromboinflammation; neutrophil extracellular trap formation; dialysate composition; cellular activation; transcriptome analysis

Outcome Measures

Primary Outcomes (1)

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

  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)

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

Secondary Outcomes (4)

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

  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 and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition

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

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

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

Study Arms (3)

Acetic acid dialysate (0.5 mmol/L Mg)

ACTIVE COMPARATOR

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.

Other: Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L

Citric acid dialysate (Mg 1.0 mmol/L)

ACTIVE COMPARATOR

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

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

Citric acid dialysate (Mg 0.75 mmol/L)

ACTIVE COMPARATOR

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

Other: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L

Interventions

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.

Citric acid dialysate (Mg 1.0 mmol/L)

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.

Acetic acid dialysate (0.5 mmol/L Mg)

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.

Citric acid dialysate (Mg 0.75 mmol/L)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants to the OMAGOD pilot trial

You may not qualify if:

• Patients who are not participating in the OMAGOD pilot trial

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead
• University of Rochester: collaborator
• Vrije Universiteit Brussel, Jette, Belgium: collaborator

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Thromboinflammation; Kidney Failure, Chronic

Interventions

Magnesium

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florine Janssens, Medical doctor

CONTACT

+324749435; florine.janssens@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 4, 2025
• First Posted: October 3, 2025
• Study Start: June 5, 2025
• Primary Completion: November 30, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-06

Locations

BE (1)