Endstage Renal DiseasePhase 2NCT02977117
The Effect of Increasing Dialysate Magnesium on Calcification Propensity in Subjects on Haemodialysis
A Phase 2 study testing Dialysate magnesium (1.0 mmol/L) and Dialysate magnesium (0.5 mmol/L) in people with Endstage Renal Disease, run by Iain Bressendorff at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endstage Renal Disease
- What is being tested?
- Dialysate magnesium (1.0 mmol/L) and Dialysate magnesium (0.5 mmol/L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2016to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Endstage Renal Disease
- Being tested
- Dialysate magnesium (1.0 mmol/L), Dialysate magnesium (0.5 mmol/L)
- Keywords
- magnesium, ectopic calcification, chronic kidney disease - mineral and bone disorder, serum calcification propensity
- Medical subject headings
- Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate magnesium (1.0 mmol/L)Other
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 (0.5 mmol/L)Other
Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.
| Study group | Role | What they receive |
|---|---|---|
| Dialysate magnesium 1.0 mmol/L | Experimental | Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L. Receives: Other: Dialysate magnesium (1.0 mmol/L) |
| Dialysate magnesium 0.5 mmol/L | Active comparator | Maintain dialysate magnesium at 0.5 mmol/L. Receives: Other: Dialysate magnesium (0.5 mmol/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in serum calcification propensity at follow-up
Measured: 4 weeks
Secondary outcomes (7)
Within-group change in serum calcification propensity
Measured: 2 weeks
Within-group change and between-group difference in serum magnesium
Measured: 4 weeks
Change in serum magnesium after intervention
Measured: 2 weeks
Within-group change and between-group difference in serum parathyroid hormone
Measured: 4 weeks
Change in serum parathyroid hormone after intervention
Measured: 2 weeks
Change in fibroblast growth factor 23 during intervention
Measured: 4 weeks
Incidence of intradialytic hypotension during intervention
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endstage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iain Bressendorff
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Iain Bressendorff, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977117
- Sponsor's protocol ID
- Nordsjaellands Hospital
- Status last verified
- Jun 2018
- First submitted
- 27 Nov 2016
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02977117
- Acronym / sponsor ID
- Nordsjaellands Hospital
- Conditions
- Endstage Renal Disease
- Keywords
- magnesium, ectopic calcification, chronic kidney disease - mineral and bone disorder, serum calcification propensity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Iain BressendorffUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialysate magnesium 1.0 mmol/L | Experimental | Other: Dialysate magnesium (1.0 mmol/L)Increase dialysate magnesium from 0.5 mmol/L to 1.0 mmol/L. |
| Dialysate magnesium 0.5 mmol/L | Active comparator | Other: Dialysate magnesium (0.5 mmol/L)Maintain dialysate magnesium at 0.5 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 1.0 mmol/L |
| Dialysate magnesium (0.5 mmol/L)Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial. | Other | Dialysate magnesium 0.5 mmol/L |
Primary outcome
Between-group difference in serum calcification propensity at follow-up
Time frame: 4 weeks
7 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dialysate magnesium (1.0 mmol/L) and Dialysate magnesium (0.5 mmol/L) in people with Endstage Renal Disease, run by Iain Bressendorff at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in serum calcification propensity at follow-up (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.