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Completed

NCT Number: NCT02977117

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. Within-group change in serum calcification propensity

    Time frame: 2 weeks

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

    Time frame: 4 weeks

  3. Change in serum magnesium after intervention

    Time frame: 2 weeks

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

    Time frame: 4 weeks

  5. Change in serum parathyroid hormone after intervention

    Time frame: 2 weeks

  6. Change in fibroblast growth factor 23 during intervention

    Time frame: 4 weeks

  7. Incidence of intradialytic hypotension during intervention

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Iain Bressendorff

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 30, 2016
Registry last updated
Jun 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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