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

The Effect of Increasing Dialysate Magnesium on Serum Calcification Propensity in Subjects With End-Stage Renal Disease Treated With Haemodialysis - A Randomised Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Endstage Renal Disease
• Intervention / Treatment: Other: Dialysate magnesium (1.0 mmol/L); Other: Dialysate magnesium (0.5 mmol/L)

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 Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Hillerod, Denmark, 3400
    • Iain Bressendorff

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dialysate magnesium 1.0 mmol/L; Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.	Other: Dialysate magnesium (1.0 mmol/L); 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.
Active Comparator: Dialysate magnesium 0.5 mmol/L; Maintain dialysate magnesium at 0.5 mmol/L.	Other: Dialysate magnesium (0.5 mmol/L); Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Between-group difference in serum calcification propensity at follow-up	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Iain Bressendorff

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 27, 2016
• First Submitted That Met QC Criteria: November 29, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2018
• Last Update Submitted That Met QC Criteria: June 4, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: magnesium; ectopic calcification; chronic kidney disease - mineral and bone disorder; serum calcification propensity
• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Calcium Metabolism Disorders; Kidney Diseases; Kidney Failure, Chronic; Calcinosis; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: Nordsjaellands Hospital