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History of Changes for Study: NCT02977117
The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis
Latest version (submitted June 4, 2018) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 29, 2016 None (earliest Version on record)
2 November 30, 2016 Study Status
3 March 3, 2017 Study Status and Eligibility
4 June 13, 2017 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 June 4, 2018 Outcome Measures and Study Status
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Study NCT02977117
Submitted Date:  November 29, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: Nordsjaellands Hospital
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2016
Overall Status: Recruiting
Study Start: November 2016
Primary Completion: July 2017 [Anticipated]
Study Completion:
First Submitted: November 27, 2016
First Submitted that
Met QC Criteria:
November 29, 2016
First Posted: November 30, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 29, 2016
Last Update Posted: November 30, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Iain Bressendorff
Responsible Party: Sponsor-Investigator
Investigator: Iain Bressendorff
Official Title: MD
Affiliation: Nordsjaellands Hospital
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module 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.

Open or close this module Conditions
Conditions: Endstage Renal Disease
Keywords: magnesium
ectopic calcification
chronic kidney disease - mineral and bone disorder
serum calcification propensity
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 72 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Dialysate magnesium 1.0 mmol/L
Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
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.
Dialysate magnesium (0.5 mmol/L)
Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Change in serum calcification propensity during intervention
[ Time Frame: 4 weeks ]

Secondary Outcome Measures:
1. Change in serum calcification propensity after intervention
[ Time Frame: 2 weeks ]

2. Change in serum magnesium during intervention
[ Time Frame: 4 weeks ]

3. Change in serum magnesium after intervention
[ Time Frame: 2 weeks ]

4. Change in serum parathyroid hormone during intervention
[ 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. Change in corrected QT interval during intervention
[ Time Frame: 4 weeks ]

8. Incidence of intradialytic hypotension during intervention
[ Time Frame: 4 weeks ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Age ≥ 18 years.
  • Treatment with thrice-weekly maintenance haemodialysis for more than 3 months.
  • Dialysate magnesium of 0.5 mmol/L (standard concentration).
  • Serum magnesium < 1.0 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.
Open or close this module Contacts/Locations
Locations: Denmark
Iain Bressendorff
[Recruiting]
Hillerod, Denmark, 3400
Contact:Contact: Iain B Bressendorff, MD +4524277139 iain.bressendorff@regionh.dk
Contact:Contact: Lisbet Brandi, MD DMSc +4548295993 lisbet.brandi@regionh.dk
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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