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

NCT ID: NCT02977117

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2017-06-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Dialysate magnesium 1.0 mmol/L

Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.

Group Type: EXPERIMENTAL

Dialysate magnesium (1.0 mmol/L)

Intervention Type: 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

Maintain dialysate magnesium at 0.5 mmol/L.

Group Type: ACTIVE_COMPARATOR

Dialysate magnesium (0.5 mmol/L)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Dialysate magnesium (0.5 mmol/L)

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Iain Bressendorff

OTHER

Sponsor Role: lead

Responsible Party

Iain Bressendorff

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Iain Bressendorff

Hillerød, , Denmark

Countries

Denmark

Other Identifiers

Nordsjaellands Hospital

Identifier Type: -

Identifier Source: org_study_id