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Completed

NCT Number: NCT07565779

Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel, Brussels, Brussels Capital, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

A - Dialysate magnesium 0.75

Device

Citrate-based concentrate with magnesium 0.75 mmol/l

Other names: Intervention A

B - Dialysate magnesium 1.00 mmol/L

Device

Citrate-based concentrate with magnesium 1.00 mmol/l

Other names: Intervention B

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean predialysis Magnesium

    Time frame: 2 weeks

    Average serum predialysis total Mg on day 15 after intervention/comparator

  2. Mean predialysis ionized Magnesium

    Time frame: 2 weeks

    Average serum predialysis ionized Mg on day 15 after the intervention/comparator

  3. Mean postdialysis ionized Magnesium

    Time frame: 2 weeks

    Average serum postdialysis ionized Mg on day 15 after intervention/comparator

  4. Proportion low predialysis magnesium

    Time frame: 2 weeks

    Proportion of patients with predialysis Mg <1,05 mmol/L on day 15 of the intervention

  5. Proportion high predialysis magnesium

    Time frame: 2 weeks

    Proportion of patients with predialysis Mg >1,5 mmol/L on day 15 of the intervention

  6. Cardiac safety endpoint 1

    Time frame: 2 weeks

    occurrance of cardiac arrythmias

  7. Cardiac safety endpoint 2

    Time frame: 2 weeks

    Change in QTc-interval in milliseconds

Other outcomes

  1. Exploratory 1 - muscle cramps

    Time frame: 2 weeks

    muscle cramps

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • Fresenius AG

Registry information

Official study title

Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels: a Randomized Single-blind Crossover Study: Pilot-OMAGOD

Acronym: OMAGOD-1

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 4, 2026
Registry last updated
May 4, 2026

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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