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

Phase 2

Completed

• Conditions: Endstage Renal Disease
• Interventions: Other: Dialysate magnesium (1.0 mmol/L); Other: Dialysate magnesium (0.5 mmol/L)

• Registration Number: NCT02977117
• Lead Sponsor: Iain Bressendorff

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2016-11-27
• Study First Submitted QC: 2016-11-29
• Study First Posted: 2016-11-30
• Study Start: 2016-12
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dialysate magnesium 1.0 mmol/L	Dialysate magnesium (1.0 mmol/L)	Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
Dialysate magnesium 0.5 mmol/L	Dialysate magnesium (0.5 mmol/L)	Maintain dialysate magnesium at 0.5 mmol/L.

Primary Outcome Measures

Name	Time	Method
Between-group difference in serum calcification propensity at follow-up	4 weeks

Secondary Outcome Measures

Name	Time	Method
Within-group change in serum calcification propensity	2 weeks
Within-group change and between-group difference in serum magnesium	4 weeks
Change in serum magnesium after intervention	2 weeks
Within-group change and between-group difference in serum parathyroid hormone	4 weeks
Change in serum parathyroid hormone after intervention	2 weeks
Change in fibroblast growth factor 23 during intervention	4 weeks
Incidence of intradialytic hypotension during intervention	4 weeks

Trial Locations

Locations (1)

Iain Bressendorff; 🇩🇰 Hillerod, Denmark