Chronic Kidney DiseasePhase 2MagiCal-CKDNCT02542319
Effect of Oral Magnesium on Vascular Calcification in Chronic Kidney Disease
A Phase 2 study testing Mablet 360 mg in people with Chronic Kidney Disease and Vascular Calcification, run by Nordsjaellands Hospital at 3 sites in 2 countries.
Trial summary
Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Vascular Calcification, Uremic Osteodystrophy
- What is being tested?
- Mablet 360 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Nov 2015to Jul 2021
- 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
- Estimated glomerular filtration rate between 45 and 15 mL/min for > 3 months (i.e. CKD stage 3b-4).
- Serum total magnesium < 0,82 mmol/L and serum phosphate > 1,15 mmol/L on average of previous measurements.
- or Serum total magnesium < 0,92 mmol/L and serum phosphate > 1,30 mmol/L on average of previous measurements.
- Life expectancy > 1 year.
- Expected time until initiation of dialysis or transplantation > 1 year.
- 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
- Current hemodialysis or peritoneal dialysis treatment.
- Kidney donor recipient.
- Previous coronary artery bypass graft (CABG).
- Parathyroid hormone > 600 ρmol/L.
- Previous parathyroidectomy.
- Current treatment with magnesium containing medication or supplements.
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- Any condition impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis).
- Active malignancy (basal or squamous cell skin carcinoma, localized prostate cancer and cancer with no signs of reoccurrence after 5 years are exempt from this).
- Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of trial.
- Pregnancy or breastfeeding.
- Allergy towards contents of interventional medication.
- Participation in other interventional trials.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Denmark2 sites
Herlev Hospital
Herlev, 2730
Nordsjællands Hospital
Hillerød, 3400
About this study
Official title: The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial
Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.
Read the detailed description
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in CKD by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.
- Being tested
- Mablet 360 mg, Placebo
- Medical subject headings
- Renal Insufficiency, Chronic, Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mablet 360 mgDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Magnesium | Experimental | Oral Magnesium Hydroxide (Mablet 360 mg) twice daily for 12 months. Receives: Dietary Supplement: Mablet 360 mg |
| Placebo | Placebo comparator | Matching placebo tablets twice daily for 12 months. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary Artery Calcification (CAC) score
Agatston score assessed by CT scan.
Measured: 12 months
Secondary outcomes (3)
Bone Mineral Density (BMD)
BMD assessed by quantitative CT.
Measured: 12 months
Pulse Wave Velocity
Measured: 12 months.
Serum Calcification Propensity
Serum calcification propensity assessed by T50 analysis.
Measured: 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study startNov 2015
- Primary completionNov 2020
- Study completionJul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital
- Responsible party
- Sponsor
- Investigators
- Iain O Bressendorff, MD, PhD, Principal investigator, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542319
- Sponsor's protocol ID
- MagiCal-CKD
- Acronym
- MagiCal-CKD
- Status last verified
- Jun 2018
- First submitted
- 3 Sep 2015
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bressendorff I, Hansen D, Schou M, Kragelund C, Svensson M, Hashemi B, Kristensen T, Vrist MH, Borg R, Tougaard B, Borg K, Hjortkjaer HO, Kristiansen CH, Carlson N, Nasiri M, Ashraf H, Pasch A, Brandi L. The Effect of Magnesium Supplementation on Vascular Calcification in CKD: A Randomized Clinical Trial (MAGiCAL-CKD). J Am Soc Nephrol. 2023 May 1;34(5):886-894. doi: 10.1681/ASN.0000000000000092. Epub 2023 Feb 2.
PubMed 36749131Bressendorff I, Hansen D, Schou M, Kragelund C, Brandi L. The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. BMJ Open. 2017 Jun 23;7(6):e016795. doi: 10.1136/bmjopen-2017-016795.
PubMed 28645983
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Magnesium Supplementation on Vascular Calcification in Chronic Kidney Disease - A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02542319
- Acronym / sponsor ID
- MagiCal-CKD / MagiCal-CKD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Herlev Hospital
- Study start
- Nov 2015
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 7 Sep 2015 (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.
Randomized placebo-controlled double-blinded interventional trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will reduce vascular calcification in subjects with chronic kidney disease while not decreasing bone mineral density.
Detailed description
Chronic kidney disease (CKD) is associated with increase cardiovascular morbidity and mortality independent of traditional cardiovascular risk factors due to increased vascular calcification. Epidemiological and experimental data suggest that hypermagnesemia and magnesium supplementation reduce vascular calcification in CKD by increasing calcium/phosphate solubility in serum, by inhibiting calcium influx into vascular smooth muscle cells (VSMC), by inhibiting intracellular pro-calcification enzymes in VSMC and by increasing activity of intracellular anti-calcification enzymes in VSMC. However, there have been concerns that any anti-calcification effect of magnesium might also reduce bone mineral density, in which case there might be an increased risk of bone fractures associated with magnesium supplementation in CKD. We wish to conduct a randomized placebo-controlled double-blinded interventional trial to examine whether oral magnesium supplementation will reduce vascular calcification in subjects with CKD while not decreasing bone mineral density.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel-group
| Arm | Type | Receives |
|---|---|---|
| Magnesium | Experimental | Dietary Supplement: Mablet 360 mgOral Magnesium Hydroxide (Mablet 360 mg) twice daily for 12 months. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatching placebo tablets twice daily for 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Estimated glomerular filtration rate between 45 and 15 mL/min for > 3 months (i.e. CKD stage 3b-4).
- Serum total magnesium < 0,82 mmol/L and serum phosphate > 1,15 mmol/L on average of previous measurements.
- or Serum total magnesium < 0,92 mmol/L and serum phosphate > 1,30 mmol/L on average of previous measurements.
- Life expectancy > 1 year.
- Expected time until initiation of dialysis or transplantation > 1 year.
Key exclusion criteria (12 listed)
- Current hemodialysis or peritoneal dialysis treatment.
- Kidney donor recipient.
- Previous coronary artery bypass graft (CABG).
- Parathyroid hormone > 600 ρmol/L.
- Previous parathyroidectomy.
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 |
|---|---|---|
| Mablet 360 mg | Dietary supplement | Magnesium |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Coronary Artery Calcification (CAC) score
Time frame: 12 months
Agatston score assessed by CT scan.
3 secondary outcomes
Bone Mineral Density (BMD)
Time frame: 12 months
Pulse Wave Velocity
Time frame: 12 months.
Serum Calcification Propensity
Time frame: 12 months.
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 Sep 2022.
- Derived from this study: PubMed 36749131Bressendorff I, Hansen D, Schou M, Kragelund C, Svensson M, Hashemi B, Kristensen T, Vrist MH, Borg R, Tougaard B, Borg K, Hjortkjaer HO, Kristiansen CH, Carlson N, Nasiri M, Ashraf H, Pasch A, Brandi L. The Effect of Magnesium Supplementation on Vascular Calcification in CKD: A Randomized Clinical Trial (MAGiCAL-CKD). J Am Soc Nephrol. 2023 May 1;34(5):886-894. doi: 10.1681/ASN.0000000000000092. Epub 2023 Feb 2.
- Derived from this study: PubMed 28645983Bressendorff I, Hansen D, Schou M, Kragelund C, Brandi L. The effect of magnesium supplementation on vascular calcification in chronic kidney disease-a randomised clinical trial (MAGiCAL-CKD): essential study design and rationale. BMJ Open. 2017 Jun 23;7(6):e016795. doi: 10.1136/bmjopen-2017-016795.
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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.
Iain O Bressendorff, MD, PhD principal investigator
Nordsjaellands Hospital
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mablet 360 mg in people with Chronic Kidney Disease and Vascular Calcification, run by Nordsjaellands Hospital at 3 sites in 2 countries.
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 7 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 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Norway. 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. Some participants in this study may receive a placebo. 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?
Coronary Artery Calcification (CAC) score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542319, which also lists 2 linked publications.
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 Sep 2022.