Dialysis; ComplicationsOMAGOD-1NCT07565779
Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels
A study testing A - Dialysate magnesium 0.75 and B - Dialysate magnesium 1.00 mmol/L in people with Dialysis; Complications, run by Universitaire Ziekenhuizen KU Leuven at 4 sites in Belgium.
Trial summary
Individuals with ESKD and treated with hemodialysis have a high mortality risk. Associative studies suggest a relationship between serum magnesium concentration and mortality risk. The influence of magnesium concentration on mortality risk is unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- A - Dialysate magnesium 0.75 and B - Dialysate magnesium 1.00 mmol/L
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesBelgium
- Study dates
- 28 Jan 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Written informed consent must be obtained prior to any screening procedures
- Clinically stable during two months prior to the study. This will be based upon clinical judgement.
- On stable blood pressure medication 4 weeks prior to the study
- Dialysis with a K3 dialysate
- Adequate double-needle dialysis access (fistula or catheter)
- Able to fill questionnaire/symptom score
Who cannot join
- Predialysis calcium <1,9mmol/L during baseline
- Magnesium predialysis >1,45mmol/L during baseline
- Patient has a history of child C liver cirrhosis
- Coronary intervention <3 months before randomization
- Hospitalization <2 months before randomization
- Uncontrolled predialysis hypertension >160/90mmHg despite 4 antihypertensive drugs
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- Predialysis blood pressure <90mmHg during baseline visit
- History of dialysis access related problems <1 month before the randomization
- Chronic Atrial fibrillation
- NYHA class 4 heart failure
- Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Azorg
Aalst, Oost-Vlaanderen
UZ Brussel
Brussels, Brussels Capital, 1000
AZ groeninge
Kortrijk, West-Vlaanderen, 3621
UZ Leuven
Leuven, Vlaams-Brabant, 3000
About this study
Official title: Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels: a Randomized Single-blind Crossover Study: Pilot-OMAGOD
Individuals with ESKD and treated with hemodialysis have a high mortality risk. Associative studies suggest a relationship between serum magnesium concentration and mortality risk. The influence of magnesium concentration on mortality risk is unknown. This pilot study will explore whether altering dialysate magnesium concentration in the presence of citrate will change serum magnesium concentrations.
Read the detailed description
To determine if a citrate enriched, Mg 1.0 mmol/L dialysate, when compared to a Mg 0,75 mmol/L citrate enriched dialysate leads to a:
- higher average serum predialysis total Mg on day 15 of the intervention
- higher average serum predialysis ionized Mg on day 15 of the intervention
- higher average serum postdialysis ionized Mg on day 15 of the intervention
- smaller proportion of patients with serum predialysis Mg <1,05 mmol/L on day 15 of the intervention
- larger proportion of patients with serum predialysis Mg > 1,50 mmol/L on day 15 of the intervention
- larger difference in predialysis Mg on day 15 versus day one of the intervention.
- Conditions
- Dialysis; Complications
- Being tested
- A - Dialysate magnesium 0.75, B - Dialysate magnesium 1.00 mmol/L
- Keywords
- hemodialysis, dialysate, magnesium, muscle cramps
- Medical subject headings
- Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A - Dialysate magnesium 0.75Device
Also called Intervention A
Citrate-based concentrate with magnesium 0.75 mmol/l
B - Dialysate magnesium 1.00 mmol/LDevice
Also called Intervention B
Citrate-based concentrate with magnesium 1.00 mmol/l
| Study group | Role | What they receive |
|---|---|---|
| Arm A - B | Active comparator | Patients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l) Receives: Device: A - Dialysate magnesium 0.75; Device: B - Dialysate magnesium 1.00 mmol/L |
| Arm B - A | Active comparator | Patients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate magnesium 0.75 mmol/l) Receives: Device: A - Dialysate magnesium 0.75; Device: B - Dialysate magnesium 1.00 mmol/L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion predialysis magnesium in target range
Proportion of patients with a predialysis serum Mg concentration between 1,10 and 1,45mmol/L on day 15 of the intervention
Measured: 2 weeks
Secondary outcomes (7)
Mean predialysis Magnesium
Average serum predialysis total Mg on day 15 after intervention/comparator
Measured: 2 weeks
Mean predialysis ionized Magnesium
Average serum predialysis ionized Mg on day 15 after the intervention/comparator
Measured: 2 weeks
Mean postdialysis ionized Magnesium
Average serum postdialysis ionized Mg on day 15 after intervention/comparator
Measured: 2 weeks
Proportion low predialysis magnesium
Proportion of patients with predialysis Mg <1,05 mmol/L on day 15 of the intervention
Measured: 2 weeks
Proportion high predialysis magnesium
Proportion of patients with predialysis Mg >1,5 mmol/L on day 15 of the intervention
Measured: 2 weeks
Cardiac safety endpoint 1
occurrance of cardiac arrythmias
Measured: 2 weeks
Cardiac safety endpoint 2
Change in QTc-interval in milliseconds
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start28 Jan 2025
- Primary completion15 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- multicenter, prospective, parallel group design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius AG
- Responsible party
- Sponsor
- Investigators
- Bjorn Meijers, MD, PhD, Study chair, UZ LeuvenKarlien Francois, MD, PhD, Principal investigator, Universitair Ziekenhuis BrusselGert Meeus, MD, Principal investigator, AZ groeningheRogier Caluwé, MD, PhD, Principal investigator, AZORG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565779
- Sponsor's protocol ID
- S67800
- Acronym
- OMAGOD-1
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. 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 Serum Magnesium Levels: a Randomized Single-blind Crossover Study: Pilot-OMAGOD
- ClinicalTrials.gov ID
- NCT07565779
- Acronym / sponsor ID
- OMAGOD-1 / S67800
- Conditions
- Dialysis; Complications
- Keywords
- hemodialysis, dialysate, magnesium, muscle cramps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fresenius AG
- Study start
- 28 Jan 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 4 May 2026 (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.
Individuals with ESKD and treated with hemodialysis have a high mortality risk. Associative studies suggest a relationship between serum magnesium concentration and mortality risk. The influence of magnesium concentration on mortality risk is unknown. This pilot study will explore whether altering dialysate magnesium concentration in the presence of citrate will change serum magnesium concentrations.
Detailed description
To determine if a citrate enriched, Mg 1.0 mmol/L dialysate, when compared to a Mg 0,75 mmol/L citrate enriched dialysate leads to a:
- higher average serum predialysis total Mg on day 15 of the intervention
- higher average serum predialysis ionized Mg on day 15 of the intervention
- higher average serum postdialysis ionized Mg on day 15 of the intervention
- smaller proportion of patients with serum predialysis Mg <1,05 mmol/L on day 15 of the intervention
- larger proportion of patients with serum predialysis Mg > 1,50 mmol/L on day 15 of the intervention
- larger difference in predialysis Mg on day 15 versus day one of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- multicenter, prospective, parallel group design
| Arm | Type | Receives |
|---|---|---|
| Arm A - B | Active comparator | Device: A - Dialysate magnesium 0.75, Device: B - Dialysate magnesium 1.00 mmol/LPatients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l) |
| Arm B - A | Active comparator | Device: A - Dialysate magnesium 0.75, Device: B - Dialysate magnesium 1.00 mmol/LPatients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate 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 (6 listed)
- Written informed consent must be obtained prior to any screening procedures
- Clinically stable during two months prior to the study. This will be based upon clinical judgement.
- On stable blood pressure medication 4 weeks prior to the study
- Dialysis with a K3 dialysate
- Adequate double-needle dialysis access (fistula or catheter)
Key exclusion criteria (11 listed)
- Predialysis calcium <1,9mmol/L during baseline
- Magnesium predialysis >1,45mmol/L during baseline
- Patient has a history of child C liver cirrhosis
- Coronary intervention <3 months before randomization
- Hospitalization <2 months before randomization
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 |
|---|---|---|
| A - Dialysate magnesium 0.75Also: Intervention ACitrate-based concentrate with magnesium 0.75 mmol/l | Device | Arm A - B, Arm B - A |
| B - Dialysate magnesium 1.00 mmol/LAlso: Intervention BCitrate-based concentrate with magnesium 1.00 mmol/l | Device | Arm A - B, Arm B - A |
Primary outcome
Proportion predialysis magnesium in target range
Time frame: 2 weeks
Proportion of patients with a predialysis serum Mg concentration between 1,10 and 1,45mmol/L on day 15 of the intervention
7 secondary outcomes
Mean predialysis Magnesium
Time frame: 2 weeks
Mean predialysis ionized Magnesium
Time frame: 2 weeks
Mean postdialysis ionized Magnesium
Time frame: 2 weeks
Proportion low predialysis magnesium
Time frame: 2 weeks
Proportion high predialysis magnesium
Time frame: 2 weeks
Cardiac safety endpoint 1
Time frame: 2 weeks
Cardiac safety endpoint 2
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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. This study is not recruiting at the moment.
Bjorn Meijers, MD, PhD study chair
UZ Leuven
Karlien Francois, MD, PhD principal investigator
Universitair Ziekenhuis Brussel
Gert Meeus, MD principal investigator
AZ groeninghe
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A - Dialysate magnesium 0.75 and B - Dialysate magnesium 1.00 mmol/L in people with Dialysis; Complications, run by Universitaire Ziekenhuizen KU Leuven at 4 sites 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion predialysis magnesium in target range (time frame: 2 weeks). 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 4 May 2026.