NCT02977117

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Iain Bressendorff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endstage Renal Disease

Interventions

Type	Name	Description
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.
OTHER	Dialysate magnesium (0.5 mmol/L)	Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2016-11-30
• Last updated: 2018-06-06

Locations

1 site across 1 country: Denmark