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

Primary Purpose

Endstage Renal Disease

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Dialysate magnesium (1.0 mmol/L)

Dialysate magnesium (0.5 mmol/L)

About this trial

This is an interventional prevention trial for Endstage Renal Disease focused on measuring magnesium, ectopic calcification, chronic kidney disease - mineral and bone disorder, serum calcification propensity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Iain Bressendorff

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dialysate magnesium 1.0 mmol/L

Dialysate magnesium 0.5 mmol/L

Arm Description

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

Maintain dialysate magnesium at 0.5 mmol/L.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Within-group change in serum calcification propensity

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

Change in serum magnesium after intervention

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

Change in serum parathyroid hormone after intervention

Change in fibroblast growth factor 23 during intervention

Incidence of intradialytic hypotension during intervention

Full Information

NCT ID

NCT02977117

First Posted

November 27, 2016

Last Updated

June 4, 2018

Sponsor

Iain Bressendorff

1. Study Identification

Unique Protocol Identification Number

NCT02977117

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

December 2016 (undefined)

Primary Completion Date

June 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Iain Bressendorff

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endstage Renal Disease

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dialysate magnesium 1.0 mmol/L

Arm Type

Experimental

Arm Description

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

Arm Title

Dialysate magnesium 0.5 mmol/L

Arm Type

Active Comparator

Arm Description

Maintain dialysate magnesium at 0.5 mmol/L.

Intervention Type

Other

Intervention Name(s)

Dialysate magnesium (1.0 mmol/L)

Intervention Description

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

Intervention Name(s)

Dialysate magnesium (0.5 mmol/L)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

Within-group change in serum calcification propensity

Time Frame

2 weeks

Title

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

Time Frame

4 weeks

Title

Change in serum magnesium after intervention

Time Frame

2 weeks

Title

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

Time Frame

4 weeks

Title

Change in serum parathyroid hormone after intervention

Time Frame

2 weeks

Title

Change in fibroblast growth factor 23 during intervention

Time Frame

4 weeks

Title

Incidence of intradialytic hypotension during intervention

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Iain Bressendorff

City

Hillerod

ZIP/Postal Code

3400

Country

Denmark

12. IPD Sharing Statement

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

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