<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02977117</url>
  </required_header>
  <id_info>
    <org_study_id>Nordsjaellands Hospital</org_study_id>
    <nct_id>NCT02977117</nct_id>
  </id_info>
  <brief_title>The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Iain Bressendorff</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nordsjaellands Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to examine the effect of increasing dialyse magnesium on serum&#xD;
      calcification propensity in subjects with end-stage renal disease treated with haemodialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with end-stage renal disease (ESRD) have a 20-fold increased risk of cardiovascular&#xD;
      mortality compared to the general population. Arterial stiffness, likely due to vascular&#xD;
      calcification (VC), has been shown to predict cardiovascular mortality in ESRD. Serum&#xD;
      calcification propensity (T50) is a novel biomarker, which is believed to reflect the&#xD;
      propensity toward ectopic calcification (e.g. VC). Increasing serum magnesium (sMg) should&#xD;
      increase T50, which might in turn reduce the formation of VC in patients with ESRD. A cheap&#xD;
      and easy way of achieving this would be to increase the concentration of Mg in the dialysate&#xD;
      (dMg) of patients with ESRD treated with haemodialysis (HD).&#xD;
&#xD;
      The investigators wish to conduct a randomised controlled double-blind clinical trial to&#xD;
      examine whether increasing dMg will improve T50 in subjects with ESRD treated with HD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Between-group difference in serum calcification propensity at follow-up</measure>
    <time_frame>4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Within-group change in serum calcification propensity</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-group change and between-group difference in serum magnesium</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum magnesium after intervention</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Within-group change and between-group difference in serum parathyroid hormone</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in serum parathyroid hormone after intervention</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fibroblast growth factor 23 during intervention</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of intradialytic hypotension during intervention</measure>
    <time_frame>4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Endstage Renal Disease</condition>
  <arm_group>
    <arm_group_label>Dialysate magnesium 1.0 mmol/L</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dialysate magnesium 0.5 mmol/L</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Maintain dialysate magnesium at 0.5 mmol/L.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dialysate magnesium (1.0 mmol/L)</intervention_name>
    <description>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.</description>
    <arm_group_label>Dialysate magnesium 1.0 mmol/L</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dialysate magnesium (0.5 mmol/L)</intervention_name>
    <description>Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.</description>
    <arm_group_label>Dialysate magnesium 0.5 mmol/L</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Treatment with maintenance haemodialysis for more than 3 months.&#xD;
&#xD;
          -  Dialysate magnesium of 0.5 mmol/L (standard concentration).&#xD;
&#xD;
          -  Serum magnesium &lt; 1.2 mmol/L on average of previous measurements within the last 3&#xD;
             months.&#xD;
&#xD;
          -  Women of childbearing age must be actively using contraceptive therapy (p-pills,&#xD;
             estrogen depots or intrauterine device) as well as have a negative pregnancy test.&#xD;
&#xD;
          -  Written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with peritoneal dialysis.&#xD;
&#xD;
          -  Parathyroid hormone &gt; 66 ρmol/L.&#xD;
&#xD;
          -  Previous parathyroidectomy.&#xD;
&#xD;
          -  Current treatment with magnesium containing medication or supplements.&#xD;
&#xD;
          -  Other diseases or conditions, which, in the opinion of the site investigator, would&#xD;
             prevent participation in or completion of the trial.&#xD;
&#xD;
          -  Pregnancy or breastfeeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Iain Bressendorff</name>
      <address>
        <city>Hillerod</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>June 4, 2018</last_update_submitted>
  <last_update_submitted_qc>June 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Nordsjaellands Hospital</investigator_affiliation>
    <investigator_full_name>Iain Bressendorff</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>magnesium</keyword>
  <keyword>ectopic calcification</keyword>
  <keyword>chronic kidney disease - mineral and bone disorder</keyword>
  <keyword>serum calcification propensity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
    <mesh_term>Calcinosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dialysis Solutions</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02977117
org study id: Nordsjaellands Hospital
nct id: NCT02977117
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Between-group difference in serum calcification propensity at follow-up
time frame: 4 weeks
measure: Within-group change in serum calcification propensity
time frame: 2 weeks
measure: Within-group change and between-group difference in serum magnesium
time frame: 4 weeks
measure: Change in serum magnesium after intervention
time frame: 2 weeks
measure: Within-group change and between-group difference in serum parathyroid hormone
time frame: 4 weeks
measure: Change in serum parathyroid hormone after intervention
time frame: 2 weeks
measure: Change in fibroblast growth factor 23 during intervention
time frame: 4 weeks
measure: Incidence of intradialytic hypotension during intervention
time frame: 4 weeks
arm group label: Dialysate magnesium 1.0 mmol/L
arm group type: Experimental
description: Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L.
arm group label: Dialysate magnesium 0.5 mmol/L
arm group type: Active Comparator
description: Maintain dialysate magnesium at 0.5 mmol/L.
intervention type: Other
intervention name: Dialysate magnesium (1.0 mmol/L)
description: 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.
arm group label: Dialysate magnesium 1.0 mmol/L
intervention type: Other
intervention name: Dialysate magnesium (0.5 mmol/L)
description: Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.
arm group label: Dialysate magnesium 0.5 mmol/L
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Nordsjaellands Hospital
investigator full name: Iain Bressendorff
investigator title: MD
mesh term: Kidney Diseases
mesh term: Kidney Failure, Chronic
mesh term: Calcinosis
mesh term: Dialysis Solutions