Chronic Kidney DiseasesNCT03698422
Diurnal Variation in Markers of Mineral and Bone Disease in Chronic Kidney Disease
An observational study of Chronic Kidney Diseases and Mineral Metabolism Disorder, run by Herlev Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to examine whether there are diurnal variations in magnesium and other markers related to mineral metabolism in blood from patients with chronic kidney disease (CKD) compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Mineral Metabolism Disorder
- What is being tested?
- Blood and urine samples
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Oct 2018to 30 Jun 2019
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: For healthy controls: estimated glomerular filtration rate (eGFR) > 60 mL/min for > 3 months and no known current or chronic medical or surgical conditions. For predialysis CKD subjects: estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for > 3 months (i.e. CKD stage 4). For ESKD subjects: maintenance haemodialysis treatment for > 3 months for ESKD and with anuria (urine excretion < 100 mL/day).
Who may be able to join
- Age ≥ 18 years.
- Serum Mg between 0.7 and 1.1 mmol/L on average of previous measurements over the last 6 months.
- Serum ionised Ca between 1.10 and 1.35 mmol/L on average of previous measurements over the last 6 months.
- Serum phosphate (PO4) between 0.7 and 1.8 mmol/L on average of previous measurements over the last 6 months.
- A negative pregnancy test for women of childbearing age.
- Written informed consent.
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- For healthy controls - estimated glomerular filtration rate (eGFR) > 60 mL/min for > 3 months and no known current or chronic medical or surgical conditions.
- For predialysis CKD subjects - estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for > 3 months (i.e. CKD stage 4).
- For ESKD subjects - maintenance haemodialysis treatment for > 3 months for ESKD and with anuria (urine excretion < 100 mL/day).
Who cannot join
- Diagnosis of diabetes mellitus.
- Kidney transplant recipient.
- Parathyroid hormone (PTH) > 66 ρmol/L during the previous 3 months.
- Previous parathyroidectomy.
- Current treatment with Mg containing medication or supplements.
- Current treatment with calcimimetics.
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- Current treatment with immunosuppressive drugs.
- Active malignant disease.
- Blood haemoglobin < 6.0 mmol/L
- Any condition impairing Mg absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
- Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diurnal Variation in Markers of Mineral and Bone Disease in Chronic Kidney Disease - An Observational Study
The purpose of this study is to examine whether there are diurnal variations in magnesium and other markers related to mineral metabolism in blood from patients with chronic kidney disease (CKD) compared to healthy controls.
Read the detailed description
CKD is associated with a mortality rate 5-10 times higher than in the general population, which is driven by a high rate of cardiovascular disease. Several cohort studies have revealed an association between hypomagnesaemia and increased mortality in patients with CKD as well as faster progression of CKD. Additionally, studies in cultured vascular smooth muscle cells (VSMC) and in rodents with CKD have shown that Mg inhibits vascular calcification.
The exact mechanism behind the inhibitory effect of Mg on vascular calcification is incompletely understood, but seems to be related to an inhibitory effect on the formation and precipitation of hydroxyapatite and delayed formation of secondary calciprotein particles, both of which have been shown to induce calcification of VSMC in vitro. Mg blocks the calcium (Ca) influx across the cell membrane in the VSMC. Mg has some affinity for the Ca sensing receptor, which has been shown to be involved in the calcification of VSMC, and might thus inhibit vascular calcification in a manner similar to other calcimimetics.
Thus, increasing serum Mg has been proposed as a possible treatment to prevent vascular calcification in CKD. However, any diurnal variation in serum Mg and other markers of mineral metabolism related to vascular calcification in CKD have not previously been described. This is relevant as monitoring of treatment with Mg supplementation might potentially be dangerous, if there are significant diurnal changes in serum Mg. Therefore, we wish to conduct a prospective controlled clinical trial to investigate any diurnal changes in Mg other markers of mineral metabolism in healthy controls, patients with predialysis CKD and patients with end-stage kidney disease (ESKD).
- Being tested
- Blood and urine samples
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and urine samplesDiagnostic test
Subjects will be admitted to the Department of Nephrology, Herlev and Gentofte Hospital, Herlev, Denmark, for 24-hour observation with measurements of serum and urine at three-hour intervals.
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Estimated glomerular filtration rate (eGFR) > 60 mL/min for > 3 months and no known current or chronic medical or surgical conditions.
Blood and urine samples are collected for every 3rd hour during 24 hours Receives: Diagnostic Test: Blood and urine samples | |
| Predialysis CKD subjects | Estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for > 3 months (i.e. CKD stage 4).
Blood and urine samples are collected for every 3rd hour during 24 hours Receives: Diagnostic Test: Blood and urine samples | |
| ESKD subjects | Maintenance haemodialysis treatment for > 3 months for ESKD and with anuria (urine excretion < 100 mL/day).
Blood and urine samples are collected for every 3rd hour during 24 hours Receives: Diagnostic Test: Blood and urine samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diurnal change in serum magnesium within groups
change in serum magnesium (mmol/l) within Groups The changes within groups over several timepoints will be compared with linear mixed effect models
Measured: 24 hours
Secondary outcomes (7)
Change in serum magnesium between groups
Change in serum magnesium (mmol/l) between Groups The overall magnesium levels will be compared between groups by comparing the total mean of measurements for each group.
Measured: 24 hours
Change in ionized calcium
Change in p-ionized calcium within and between groups
Measured: 24 hours
Change in p-phosphate
Change in p-phosphate within and between groups
Measured: 24 hours
Change in p-PTH
Change in p-PTH within and between groups
Measured: 24 hours
Change in p-FGF23
Change in p-FGF23 within and between groups
Measured: 24 hours
Change in s-calcification propensity score
Change in s-calcification propensity score within and between groups
Measured: 24 hours
Change in u-magnesium
Change in u-magnesium within and between groups
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start3 Oct 2018
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ditte Hansen, Herlev Hospital
- Investigators
- Ditte Hansen, PhD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698422
- Sponsor's protocol ID
- H-18037663
- Status last verified
- Aug 2019
- First submitted
- 3 Oct 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diurnal Variation in Markers of Mineral and Bone Disease in Chronic Kidney Disease - An Observational Study
- ClinicalTrials.gov ID
- NCT03698422
- Acronym / sponsor ID
- H-18037663
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 9 Oct 2018 (actual)
- 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 study is to examine whether there are diurnal variations in magnesium and other markers related to mineral metabolism in blood from patients with chronic kidney disease (CKD) compared to healthy controls.
Detailed description
CKD is associated with a mortality rate 5-10 times higher than in the general population, which is driven by a high rate of cardiovascular disease. Several cohort studies have revealed an association between hypomagnesaemia and increased mortality in patients with CKD as well as faster progression of CKD. Additionally, studies in cultured vascular smooth muscle cells (VSMC) and in rodents with CKD have shown that Mg inhibits vascular calcification.
The exact mechanism behind the inhibitory effect of Mg on vascular calcification is incompletely understood, but seems to be related to an inhibitory effect on the formation and precipitation of hydroxyapatite and delayed formation of secondary calciprotein particles, both of which have been shown to induce calcification of VSMC in vitro. Mg blocks the calcium (Ca) influx across the cell membrane in the VSMC. Mg has some affinity for the Ca sensing receptor, which has been shown to be involved in the calcification of VSMC, and might thus inhibit vascular calcification in a manner similar to other calcimimetics.
Thus, increasing serum Mg has been proposed as a possible treatment to prevent vascular calcification in CKD. However, any diurnal variation in serum Mg and other markers of mineral metabolism related to vascular calcification in CKD have not previously been described. This is relevant as monitoring of treatment with Mg supplementation might potentially be dangerous, if there are significant diurnal changes in serum Mg. Therefore, we wish to conduct a prospective controlled clinical trial to investigate any diurnal changes in Mg other markers of mineral metabolism in healthy controls, patients with predialysis CKD and patients with end-stage kidney disease (ESKD).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | Diagnostic Test: Blood and urine samplesEstimated glomerular filtration rate (eGFR) > 60 mL/min for > 3 months and no known current or chronic medical or surgical conditions. Blood and urine samples are collected for every 3rd hour during 24 hours |
| Predialysis CKD subjects | – | Diagnostic Test: Blood and urine samplesEstimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for > 3 months (i.e. CKD stage 4). Blood and urine samples are collected for every 3rd hour during 24 hours |
| ESKD subjects | – | Diagnostic Test: Blood and urine samplesMaintenance haemodialysis treatment for > 3 months for ESKD and with anuria (urine excretion < 100 mL/day). Blood and urine samples are collected for every 3rd hour during 24 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- For healthy controls: estimated glomerular filtration rate (eGFR) > 60 mL/min for > 3 months and no known current or chronic medical or surgical conditions. For predialysis CKD subjects: estimated glomerular filtration rate (eGFR) between 30 and 15 mL/min for > 3 months (i.e. CKD stage 4). For ESKD subjects: maintenance haemodialysis treatment for > 3 months for ESKD and with anuria (urine excretion < 100 mL/day).
Key inclusion criteria (9 listed)
- Age ≥ 18 years.
- Serum Mg between 0.7 and 1.1 mmol/L on average of previous measurements over the last 6 months.
- Serum ionised Ca between 1.10 and 1.35 mmol/L on average of previous measurements over the last 6 months.
- Serum phosphate (PO4) between 0.7 and 1.8 mmol/L on average of previous measurements over the last 6 months.
- A negative pregnancy test for women of childbearing age.
Key exclusion criteria (12 listed)
- Diagnosis of diabetes mellitus.
- Kidney transplant recipient.
- Parathyroid hormone (PTH) > 66 ρmol/L during the previous 3 months.
- Previous parathyroidectomy.
- Current treatment with Mg containing medication or supplements.
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 |
|---|---|---|
| Blood and urine samplesSubjects will be admitted to the Department of Nephrology, Herlev and Gentofte Hospital, Herlev, Denmark, for 24-hour observation with measurements of serum and urine at three-hour intervals. | Diagnostic test | ESKD subjects, Healthy controls, Predialysis CKD subjects |
Primary outcome
Diurnal change in serum magnesium within groups
Time frame: 24 hours
change in serum magnesium (mmol/l) within Groups The changes within groups over several timepoints will be compared with linear mixed effect models
7 secondary outcomes
Change in serum magnesium between groups
Time frame: 24 hours
Change in ionized calcium
Time frame: 24 hours
Change in p-phosphate
Time frame: 24 hours
Change in p-PTH
Time frame: 24 hours
Change in p-FGF23
Time frame: 24 hours
Change in s-calcification propensity score
Time frame: 24 hours
Change in u-magnesium
Time frame: 24 hours
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 14 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Ditte Hansen, PhD principal investigator
Herlev Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Mineral Metabolism Disorder, run by Herlev Hospital 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 9 inclusion and 12 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 14 Aug 2019. 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.
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?
Diurnal change in serum magnesium within groups (time frame: 24 hours). 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 14 Aug 2019.