Effect of Modifying Magnesium Concentration in Citrate-enriched Dialysate on Serum Magnesium Levels (OMAGOD-1)

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.

Study Overview

• Status: Completed
• Conditions: Dialysis; Complications
• Intervention / Treatment: Device: A - Dialysate magnesium 0.75; Device: B - Dialysate magnesium 1.00 mmol/L

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 Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Brussels, Brussels Capital, Belgium, 1000
      • UZ Brussel
  • Oost-Vlaanderen
    • Aalst, Oost-Vlaanderen, Belgium
      • AZORG
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • UZ Leuven
  • West-Vlaanderen
    • Kortrijk, West-Vlaanderen, Belgium, 3621
      • AZ Groeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Written informed consent must be obtained prior to any screening procedures
2. Clinically stable during two months prior to the study. This will be based upon clinical judgement.
3. On stable blood pressure medication 4 weeks prior to the study
4. Dialysis with a K3 dialysate
5. Adequate double-needle dialysis access (fistula or catheter)
6. Able to fill questionnaire/symptom score

Exclusion Criteria:

1. Predialysis calcium <1,9mmol/L during baseline
2. Magnesium predialysis >1,45mmol/L during baseline
3. Patient has a history of child C liver cirrhosis
4. Coronary intervention <3 months before randomization
5. Hospitalization <2 months before randomization
6. Uncontrolled predialysis hypertension >160/90mmHg despite 4 antihypertensive drugs
7. Predialysis blood pressure <90mmHg during baseline visit
8. History of dialysis access related problems <1 month before the randomization
9. Chronic Atrial fibrillation
10. NYHA class 4 heart failure
11. Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the CIP.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm A - B; Patients undergo treatment with intervention A (dialysate magnesium 0.75 mmol), followed by intervention B (dialysate magnesium 1.00 mmol/l)	Device: A - Dialysate magnesium 0.75; Citrate-based concentrate with magnesium 0.75 mmol/l; Other Names: Intervention A; Device: B - Dialysate magnesium 1.00 mmol/L; Citrate-based concentrate with magnesium 1.00 mmol/l; Other Names: Intervention B
Active Comparator: Arm B - A; Patients undergo treatment with intervention B (dialysate magnesium 1.00 mmol), followed by intervention A (dialysate magnesium 0.75 mmol/l)	Device: A - Dialysate magnesium 0.75; Citrate-based concentrate with magnesium 0.75 mmol/l; Other Names: Intervention A; Device: B - Dialysate magnesium 1.00 mmol/L; Citrate-based concentrate with magnesium 1.00 mmol/l; Other Names: Intervention B

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean predialysis Magnesium	Average serum predialysis total Mg on day 15 after intervention/comparator	2 weeks
Mean predialysis ionized Magnesium	Average serum predialysis ionized Mg on day 15 after the intervention/comparator	2 weeks
Mean postdialysis ionized Magnesium	Average serum postdialysis ionized Mg on day 15 after intervention/comparator	2 weeks
Proportion low predialysis magnesium	Proportion of patients with predialysis Mg <1,05 mmol/L on day 15 of the intervention	2 weeks
Proportion high predialysis magnesium	Proportion of patients with predialysis Mg >1,5 mmol/L on day 15 of the intervention	2 weeks
Cardiac safety endpoint 1	occurrance of cardiac arrythmias	2 weeks
Cardiac safety endpoint 2	Change in QTc-interval in milliseconds	2 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory 1 - muscle cramps	muscle cramps	2 weeks

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: Fresenius AG
• Investigators: Study Chair: Bjorn Meijers, MD, PhD, UZ Leuven; Principal Investigator: Karlien Francois, MD, PhD, Universitair Ziekenhuis Brussel; Principal Investigator: Gert Meeus, MD, AZ groeninghe; Principal Investigator: Rogier Caluwé, MD, PhD, AZORG

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2025
• Primary Completion (Actual): January 15, 2026
• Study Completion (Actual): January 31, 2026

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hemodialysis; magnesium; muscle cramps; dialysate
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Muscle Cramp
• Other Study ID Numbers: S67800

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No