The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2016
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 6, 2018
June 1, 2018
6 months
November 27, 2016
June 4, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Between-group difference in serum calcification propensity at follow-up
4 weeks
Secondary Outcomes (7)
Within-group change in serum calcification propensity
2 weeks
Within-group change and between-group difference in serum magnesium
4 weeks
Change in serum magnesium after intervention
2 weeks
Within-group change and between-group difference in serum parathyroid hormone
4 weeks
Change in serum parathyroid hormone after intervention
2 weeks
- +2 more secondary outcomes
Study Arms (2)
Dialysate magnesium 1.0 mmol/L
EXPERIMENTALIncrease dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
Dialysate magnesium 0.5 mmol/L
ACTIVE COMPARATORMaintain dialysate magnesium at 0.5 mmol/L.
Interventions
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 will be maintained at 0.5 mmol/L for the duration of the trial.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Iain Bressendorff
Hillerød, 3400, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
November 27, 2016
First Posted
November 30, 2016
Study Start
December 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 6, 2018
Record last verified: 2018-06