The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis

Iain Bressendorff59 enrolled

Overview

The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum calcification propensity in subjects with end-stage renal disease treated with haemodialysis.

Patients with end-stage renal disease (ESRD) have a 20-fold increased risk of cardiovascular mortality compared to the general population. Arterial stiffness, likely due to vascular calcification (VC), has been shown to predict cardiovascular mortality in ESRD. Serum calcification propensity (T50) is a novel biomarker, which is believed to reflect the propensity toward ectopic calcification (e.g. VC). Increasing serum magnesium (sMg) should increase T50, which might in turn reduce the formation of VC in patients with ESRD. A cheap and easy way of achieving this would be to increase the concentration of Mg in the dialysate (dMg) of patients with ESRD treated with haemodialysis (HD). The investigators wish to conduct a randomised controlled double-blind clinical trial to examine whether increasing dMg will improve T50 in subjects with ESRD treated with HD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Endstage Renal Disease

Interventions

Dialysate magnesium (1.0 mmol/L)OTHER

Dialysate magnesium will be increased from 0.5 mmol/L to 1.0 mmol/L for 4 weeks after which subjects will return to dialysate magnesium 0.5 mmol/L for 2 weeks observation.

Dialysate magnesium (0.5 mmol/L)OTHER

Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years. * Treatment with maintenance haemodialysis for more than 3 months. * Dialysate magnesium of 0.5 mmol/L (standard concentration). * Serum magnesium \< 1.2 mmol/L on average of previous measurements within the last 3 months. * Women of childbearing age must be actively using contraceptive therapy (p-pills, estrogen depots or intrauterine device) as well as have a negative pregnancy test. * Written informed consent. Exclusion Criteria: * Treatment with peritoneal dialysis. * Parathyroid hormone \> 66 ρmol/L. * Previous parathyroidectomy. * Current treatment with magnesium containing medication or supplements. * Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial. * Pregnancy or breastfeeding.

Locations (1)

Iain Bressendorff

Hillerød, Denmark

Outcomes

Primary Outcomes

Between-group difference in serum calcification propensity at follow-up

Time frame: 4 weeks

Secondary Outcomes

Within-group change in serum calcification propensity

Time frame: 2 weeks

Within-group change and between-group difference in serum magnesium

Time frame: 4 weeks

Change in serum magnesium after intervention

Time frame: 2 weeks

Within-group change and between-group difference in serum parathyroid hormone

Time frame: 4 weeks

Change in serum parathyroid hormone after intervention

Time frame: 2 weeks

Change in fibroblast growth factor 23 during intervention

Time frame: 4 weeks

Incidence of intradialytic hypotension during intervention

Time frame: 4 weeks

Data from ClinicalTrials.gov

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