Hemodialysispilot OMAGOD +NCT07206524
Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation
A study testing Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L and Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L in people with Hemodialysis and Thromboinflammation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis, Thromboinflammation, Hemodialysis Complication
- What is being tested?
- Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L and Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants to the OMAGOD pilot trial
Who cannot join
- Patients who are not participating in the OMAGOD pilot trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, 1090
Florine Janssens, Medical doctor, +3224749435, florine.janssens@uzbrussel.be
Nathalie Marmitte, Study coordinator, +322477 6224, studiesnefrologie@uzbrussel.be
About this study
Official title: Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
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.
Read more
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)
- Being tested
- Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L, Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L
- Keywords
- hemodialysis, thromboinflammation, neutrophil extracellular trap formation, dialysate composition, cellular activation, transcriptome analysis
- Medical subject headings
- Thromboinflammation, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/LOther
Change dialysate compositions being used during hemodialysis treatment in each arm.
Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/LOther
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/LOther
Dialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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 Receives: Other: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
differences in platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialysate composition, evaluated by hematologic cell analyzer
Measured: 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
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.
Measured: 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
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.
Measured: 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
Quantification of NET biomarkers in blood and rinse fluids in relation to the dialysate composition.
Measured: Midweek dialysis session during the final week of each treatment period - week 3 (session 9), week 5 (session 15), week 7 (session 21)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start5 Jun 2025
- Primary completion30 Nov 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rochester, Vrije Universiteit Brussel
- Responsible party
- Sponsor
- Investigators
- Florine Janssens, Medical doctor, 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)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206524
- Sponsor's protocol ID
- 25113_PILOTOMAGOD
- Acronym
- pilot OMAGOD +
- Status last verified
- Jun 2025
- First submitted
- 4 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Hemodialysis-associated Thromboinflammation: a Local Pilot OMAGOD Plus Trial
- ClinicalTrials.gov ID
- NCT07206524
- Acronym / sponsor ID
- pilot OMAGOD + / 25113_PILOTOMAGOD
- Conditions
- Hemodialysis, Thromboinflammation, Hemodialysis Complication, End Stage Renal Disease (ESRD)
- Keywords
- hemodialysis, thromboinflammation, neutrophil extracellular trap formation, dialysate composition, cellular activation, transcriptome analysis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- University of Rochester, Vrije Universiteit Brussel
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Acetic acid dialysate (0.5 mmol/L Mg) | Active comparator | Other: Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/LStandardized 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. |
| Citric acid dialysate (Mg 1.0 mmol/L) | Active comparator | Other: Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/LStandardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citric acid dialysate containing magnesium 1.0 mmol/L |
| Citric acid dialysate (Mg 0.75 mmol/L) | Active comparator | Other: Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/LStandardized hemodialysis treatments 3x4hours/week. Intervention: 2 weeks (six hemodialysis sessions) using a citrate-enriched dialysate containing magnesium 0.75 mmol/L |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants to the OMAGOD pilot trial
Key exclusion criteria (1 listed)
- Patients who are not participating in the OMAGOD pilot trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/LChange dialysate compositions being used during hemodialysis treatment in each arm. | Other | Citric acid dialysate (Mg 1.0 mmol/L) |
| Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/LStandard dialysate containing acetic acid and magnesium at a concentration of 0.5 mmol/L, used during hemodialysis sessions. | Other | Acetic acid dialysate (0.5 mmol/L Mg) |
| Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/LDialysate containing citric acid and magnesium at a concentration of 0.75 mmol/L, used during hemodialysis sessions. | Other | Citric acid dialysate (Mg 0.75 mmol/L) |
Primary outcome
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)
4 secondary outcomes
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 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 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florine Janssens, Medical doctor 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)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemodialysis using dialysate containing citric acid and magnesium at a concentration of 1.0 mmol/L, Hemodialysis using acetic acid dialysate with magnesium 0.5 mmol/L and Hemodialysis using citric acid dialysate with magnesium 0.75 mmol/L in people with Hemodialysis and Thromboinflammation, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florine Janssens, Medical doctor (+324749435, florine.janssens@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025; AzTrials last refreshed its copy on 6 Nov 2026.