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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 27, 2016
First Posted Date  ICMJE November 30, 2016
Last Update Posted Date June 6, 2018
Study Start Date  ICMJE December 2016
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
Between-group difference in serum calcification propensity at follow-up [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
Change in serum calcification propensity during intervention [ Time Frame: 4 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Endstage Renal Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2017)
59
Original Estimated Enrollment  ICMJE
 (submitted: November 29, 2016)
72
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02977117
Other Study ID Numbers  ICMJE Nordsjaellands Hospital
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Iain Bressendorff, Nordsjaellands Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Iain Bressendorff
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nordsjaellands Hospital
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP