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

• ClinicalTrials.gov Identifier: NCT02977117
• Recruitment Status: Completed
• First Posted: November 30, 2016
• Last Update Posted: June 6, 2018
• Sponsor: Iain Bressendorff
• Information provided by (Responsible Party): Iain Bressendorff, Nordsjaellands Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Endstage Renal Disease	Other: Dialysate magnesium (1.0 mmol/L); Other: Dialysate magnesium (0.5 mmol/L)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Study Start Date: December 2016
• Actual Primary Completion Date: June 2017
• Actual Study Completion Date: June 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Between-group difference in serum calcification propensity at follow-up [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

Denmark

Iain Bressendorff

Hillerod, Denmark, 3400

Sponsors and Collaborators

Iain Bressendorff

More Information

• Responsible Party: Iain Bressendorff, MD, Nordsjaellands Hospital
• ClinicalTrials.gov Identifier: NCT02977117
• Other Study ID Numbers: Nordsjaellands Hospital
• First Posted: November 30, 2016
• Last Update Posted: June 6, 2018
• Last Verified: June 2018

Keywords provided by Iain Bressendorff, Nordsjaellands Hospital:

magnesium; ectopic calcification; chronic kidney disease - mineral and bone disorder; serum calcification propensity

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Calcinosis; Urologic Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Dialysis Solutions; Pharmaceutical Solutions