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

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

Tracking Information

• First Submitted Date: November 27, 2016
• First Posted Date: November 30, 2016
• Last Update Posted Date: June 6, 2018
• Study Start Date: December 2016
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 4, 2018): Between-group difference in serum calcification propensity at follow-up [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures (submitted: November 29, 2016): Change in serum calcification propensity during intervention [ Time Frame: 4 weeks ]

Current Secondary Outcome Measures (submitted: June 4, 2018)

• Within-group change in serum calcification propensity [ Time Frame: 2 weeks ]
• Within-group change and between-group difference in serum magnesium [ Time Frame: 4 weeks ]
• Change in serum magnesium after intervention [ Time Frame: 2 weeks ]
• Within-group change and between-group difference in serum parathyroid hormone [ Time Frame: 4 weeks ]
• Change in serum parathyroid hormone after intervention [ Time Frame: 2 weeks ]
• Change in fibroblast growth factor 23 during intervention [ Time Frame: 4 weeks ]
• Incidence of intradialytic hypotension during intervention [ Time Frame: 4 weeks ]

Original Secondary Outcome Measures (submitted: November 29, 2016)

• Change in serum calcification propensity after intervention [ Time Frame: 2 weeks ]
• Change in serum magnesium during intervention [ Time Frame: 4 weeks ]
• Change in serum magnesium after intervention [ Time Frame: 2 weeks ]
• Change in serum parathyroid hormone during intervention [ Time Frame: 4 weeks ]
• Change in serum parathyroid hormone after intervention [ Time Frame: 2 weeks ]
• Change in fibroblast growth factor 23 during intervention [ Time Frame: 4 weeks ]
• Change in corrected QT interval during intervention [ Time Frame: 4 weeks ]
• Incidence of intradialytic hypotension during intervention [ Time Frame: 4 weeks ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Endstage Renal Disease

Intervention

• 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.
• Other: Dialysate magnesium (0.5 mmol/L)
  Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.

Study Arms

• Experimental: Dialysate magnesium 1.0 mmol/L
  Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
  Intervention: Other: Dialysate magnesium (1.0 mmol/L)
• Active Comparator: Dialysate magnesium 0.5 mmol/L
  Maintain dialysate magnesium at 0.5 mmol/L.
  Intervention: Other: Dialysate magnesium (0.5 mmol/L)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 13, 2017): 59
• Original Estimated Enrollment (submitted: November 29, 2016): 72
• Actual Study Completion Date: June 2017
• Actual Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02977117
• Other Study ID Numbers: Nordsjaellands Hospital
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Iain Bressendorff, Nordsjaellands Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Iain Bressendorff
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nordsjaellands Hospital
• Verification Date: June 2018