NCT07565779

Brief 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. This pilot study will explore whether altering dialysate magnesium concentration in the presence of citrate will change serum magnesium concentrations.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

12 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Dialysis; Complications

Keywords

hemodialysisdialysatemagnesiummuscle cramps

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Mean predialysis Magnesium

    2 weeks

  • Mean predialysis ionized Magnesium

    2 weeks

  • Mean postdialysis ionized Magnesium

    2 weeks

  • Proportion low predialysis magnesium

    2 weeks

  • Proportion high predialysis magnesium

    2 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Exploratory 1 - muscle cramps

    2 weeks

Study Arms (2)

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)

Device: A - Dialysate magnesium 0.75Device: 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)

Device: A - Dialysate magnesium 0.75Device: B - Dialysate magnesium 1.00 mmol/L

Interventions

A - Dialysate magnesium 0.75DEVICE

Citrate-based concentrate with magnesium 0.75 mmol/l

Also known as: Intervention A
Arm A - BArm B - A
B - Dialysate magnesium 1.00 mmol/LDEVICE

Citrate-based concentrate with magnesium 1.00 mmol/l

Also known as: Intervention B
Arm A - BArm B - A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UZ Brussel

Brussels, Brussels Capital, 1000, Belgium

Location

Azorg

Aalst, Oost-Vlaanderen, Belgium

Location

UZ Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

AZ groeninge

Kortrijk, West-Vlaanderen, 3621, Belgium

Location

MeSH Terms

Conditions

Muscle Cramp

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bjorn Meijers, MD, PhD

    UZ Leuven

    STUDY CHAIR

  • Karlien Francois, MD, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Gert Meeus, MD

    AZ groeninghe

    PRINCIPAL INVESTIGATOR

  • Rogier Caluwé, MD, PhD

    AZORG

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participant-blinded, open to care providers and investigators
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: multicenter, prospective, parallel group design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

January 28, 2025

Primary Completion

January 15, 2026

Study Completion

January 31, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Locations

BE(4)