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

Endstage Renal Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977117
• Other study ID #: Nordsjaellands Hospital
• Status: Completed
• Phase: Phase 2
• Start date: December 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2018
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ?mol/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.

Related Conditions & MeSH terms

• Calcinosis
• Endstage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
Denmark	Iain Bressendorff	Hillerod

Sponsors (1)

Lead Sponsor	Collaborator
Iain Bressendorff

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Between-group difference in serum calcification propensity at follow-up		4 weeks
Secondary	Within-group change in serum calcification propensity		2 weeks
Secondary	Within-group change and between-group difference in serum magnesium		4 weeks
Secondary	Change in serum magnesium after intervention		2 weeks
Secondary	Within-group change and between-group difference in serum parathyroid hormone		4 weeks
Secondary	Change in serum parathyroid hormone after intervention		2 weeks
Secondary	Change in fibroblast growth factor 23 during intervention		4 weeks
Secondary	Incidence of intradialytic hypotension during intervention		4 weeks