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

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

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.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Magnesium

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.




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 ]


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977117


Locations
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Denmark
Iain Bressendorff
Hillerod, Denmark, 3400
Sponsors and Collaborators
Iain Bressendorff
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Responsible Party: Iain Bressendorff, MD, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT02977117    
Other Study ID Numbers: Nordsjaellands Hospital
First Posted: November 30, 2016    Key Record Dates
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:
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Kidney Diseases
Kidney Failure, Chronic
Calcinosis
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions