Chronic Kidney DiseasePhase 1/2NCT02216877
Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease
A Phase 1/2 study testing Mablet 360 mg in people with Chronic Kidney Disease and Hypomagnesemia, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium 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, Hypomagnesemia
- 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
- 36 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Apr 2015
- Phase
- Phase 1/2
- 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 (eGFR) < 60 mL/min.
- Serum magnesium < 0.82 mmol/L.
- Written informed consent.
Who cannot join
- Hemodialysis.
- Peritoneal dialysis.
- Kidney transplant recipient.
- Parathyroid hormone > 600 pg/L.
- Pregnancy.
- Comorbidity that makes study participation and completion impossible.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Medicine, Division of Nephrology, Roskilde County Hospital
Roskilde
About this study
Official title: Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
Randomized placebo-controlled interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.
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 chronic kidney disease 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. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.
- Conditions
- Chronic Kidney Disease, Hypomagnesemia
- Being tested
- Mablet 360 mg, Placebo
- Keywords
- Chronic Kidney Disease, Hypomagnesemia
- 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.
Mablet 360 mgDrug
Also called Magnesium hydroxide
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral placebo twice daily for 8 weeks. 12 subjects. Receives: Drug: Placebo |
| Mablet 360 mg once daily | Experimental | Oral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects. Receives: Drug: Mablet 360 mg; Drug: Placebo |
| Mablet 360 mg twice daily | Experimental | Oral Mablet 360 mg twice daily for 8 weeks. 12 subjects. Receives: Drug: Mablet 360 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracellular magnesium
Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
Measured: 8 weeks
Secondary outcomes (2)
Total serum magnesium
Measured: 8 weeks
Ionized serum magnesium
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iain Bressendorff, Zealand University Hospital
- Investigators
- Iain B Bressendorff, MD, Principal investigator, Department of Medicine, Division of Nephrology, Roskilde County Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216877
- Sponsor's protocol ID
- MgCKDRos
- Status last verified
- Apr 2015
- First submitted
- 12 Aug 2014
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnesium Supplementation for Hypomagnesemia in Chronic Kidney Disease - A Dose-Finding Trial
- ClinicalTrials.gov ID
- NCT02216877
- Acronym / sponsor ID
- MgCKDRos
- Conditions
- Chronic Kidney Disease, Hypomagnesemia
- Keywords
- Chronic Kidney Disease, Hypomagnesemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Aug 2014 (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 interventional trial to investigate the effect of oral magnesium supplementation on intracellular magnesium in subjects with chronic kidney disease. We hypothesize that oral magnesium supplementation will increase intracellular magnesium in subjects with chronic kidney disease as well as increase serum magnesium.
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 chronic kidney disease 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. A trial to investigate the effect of oral magnesium supplementation on vascular calcification in subjects with CKD is currently being planned, but prior to initiating such a trial it is necessary to determine the dose of oral magnesium needed to increase intracellular magnesium and serum magnesium.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOral placebo twice daily for 8 weeks. 12 subjects. |
| Mablet 360 mg once daily | Experimental | Drug: Mablet 360 mg, Drug: PlaceboOral Mablet 360 mg once daily and oral placebo once daily for 8 weeks. 12 subjects. |
| Mablet 360 mg twice daily | Experimental | Drug: Mablet 360 mgOral Mablet 360 mg twice daily for 8 weeks. 12 subjects. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Estimated Glomerular filtration rate (eGFR) < 60 mL/min.
- Serum magnesium < 0.82 mmol/L.
- Written informed consent.
Key exclusion criteria (6 listed)
- Hemodialysis.
- Peritoneal dialysis.
- Kidney transplant recipient.
- Parathyroid hormone > 600 pg/L.
- Pregnancy.
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 mgAlso: Magnesium hydroxide | Drug | Mablet 360 mg once daily, Mablet 360 mg twice daily |
| Placebo | Drug | Mablet 360 mg once daily, Placebo |
Primary outcome
Intracellular magnesium
Time frame: 8 weeks
Intracellular magnesium measured by energy dispersive x-ray analysis (www.exatest.com).
2 secondary outcomes
Total serum magnesium
Time frame: 8 weeks
Ionized serum magnesium
Time frame: 8 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 28 Apr 2015.
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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 B Bressendorff, MD principal investigator
Department of Medicine, Division of Nephrology, Roskilde County Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mablet 360 mg in people with Chronic Kidney Disease and Hypomagnesemia, run by Zealand University 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 3 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 28 Apr 2015. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Intracellular magnesium (time frame: 8 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 28 Apr 2015.