Chronic Kidney DiseasesMAGNESIRNCT05337436
Ionized Magnesium Balance During Hemodialysis Session
An observational study of Chronic Kidney Diseases, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Lymphatic drainage, Total and ionized magnesium and Total and ionized calcium
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2022to 10 Dec 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients issued from dialysis units (non profit dialysis centers)
Who may be able to join
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
- Anuric patient
Who cannot join
- Patient protected by law
- Patient under guardianship ou curatorship
- Patient deprived of liberty
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Uhmontpellier
Montpellier, 34290
Jean Paul Cristol, MD PhD, 4 67 33 83 15 ext. 33, jp-cristol@chu-montpellier.fr
Yves BOSC, MD, 430 781 868 ext. 33, j.bosc@aidersante.com
About this study
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)
- Conditions
- Chronic Kidney Diseases
- Being tested
- Lymphatic drainage, Total and ionized magnesium, Total and ionized calcium
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Ionized magnesium
- 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.
Lymphatic drainageBiological
Also called Biological determination in plasma:
Biological determination in plasma:
Total and ionized magnesiumBiological
Total and ionized magnesium
Total and ionized calciumBiological
Total and ionized calcium
| Study group | Role | What they receive |
|---|---|---|
| All patients receive conventional dialysis treatment at enrollment | All patients receive conventional dialysis treatment at enrollment Receives: Biological: Lymphatic drainage; Biological: Total and ionized magnesium; Biological: Total and ionized calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of ionized magnesium levels before and after dialysis session
Comparison of ionized magnesium levels before and after dialysis session
Measured: day 1
Secondary outcomes (7)
Comparison of total magnesium levels before and after dialysis session
Comparison of total magnesium levels before and after dialysis session
Measured: day 1
Comparison of ionized calcium levels before and after dialysis session
Comparison of ionized calcium levels before and after dialysis session
Measured: day 1
Comparison of total calcium levels before and after dialysis session
Comparison of total calcium levels before and after dialysis session
Measured: day 1
Per-dialytic balance of ionized magnesium according to predialysis level
Per-dialytic balance of ionized magnesium according to predialysis level
Measured: day 1
Per-dialytic balance of total magnesium according to predialysis level
Per-dialytic balance of total magnesium according to predialysis level
Measured: day 1
Per-dialytic balance of ionized calcium according to predialysis level
Per-dialytic balance of ionized calcium according to predialysis level
Measured: day 1
Per-dialytic balance of total calcium according to predialysis level
Per-dialytic balance of total calcium according to predialysis level
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Jul 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
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.
- More trials run by University Hospital, MontpellierThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Study director, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337436
- Sponsor's protocol ID
- RECHMPL22_0004
- Acronym
- MAGNESIR
- Status last verified
- Apr 2022
- First submitted
- 13 Apr 2022
- Last updated
- 27 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ionized Magnesium Balance During Hemodialysis Session
- ClinicalTrials.gov ID
- NCT05337436
- Acronym / sponsor ID
- MAGNESIR / RECHMPL22_0004
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease patient on dialysis (stage 5D), Extracorporeal purification, Ionized magnesium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 20 Apr 2022 (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.
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the balance of total and ionized magnesium according to different types of dialysate used in clinical practice (acetate + Mg 0.50 or 0.75 mM vs citrate + Mg 0.50 ou 0.75 mM)
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients receive conventional dialysis treatment at enrollment | – | Biological: Lymphatic drainage, Biological: Total and ionized magnesium, Biological: Total and ionized calciumAll patients receive conventional dialysis treatment at enrollment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients issued from dialysis units (non profit dialysis centers)
Key inclusion criteria (2 listed)
- Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month
- Anuric patient
Key exclusion criteria (3 listed)
- Patient protected by law
- Patient under guardianship ou curatorship
- Patient deprived of liberty
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 |
|---|---|---|
| Lymphatic drainageAlso: Biological determination in plasma:Biological determination in plasma: | Biological | All patients receive conventional dialysis treatment at enrollment |
| Total and ionized magnesiumTotal and ionized magnesium | Biological | All patients receive conventional dialysis treatment at enrollment |
| Total and ionized calciumTotal and ionized calcium | Biological | All patients receive conventional dialysis treatment at enrollment |
Primary outcome
Comparison of ionized magnesium levels before and after dialysis session
Time frame: day 1
Comparison of ionized magnesium levels before and after dialysis session
7 secondary outcomes
Comparison of total magnesium levels before and after dialysis session
Time frame: day 1
Comparison of ionized calcium levels before and after dialysis session
Time frame: day 1
Comparison of total calcium levels before and after dialysis session
Time frame: day 1
Per-dialytic balance of ionized magnesium according to predialysis level
Time frame: day 1
Per-dialytic balance of total magnesium according to predialysis level
Time frame: day 1
Per-dialytic balance of ionized calcium according to predialysis level
Time frame: day 1
Per-dialytic balance of total calcium according to predialysis level
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Individual participant dataSharing planned: Undecided. NC
Related trials for Chronic Kidney Diseases
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
RecruitingPhase 2
Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia
Chronic Kidney Disease
Not yet recruitingPhase 2
Ticagrelor for Inflammation and Cardiovascular Risk in Patients With Chronic Kidney Disease
Chronic Kidney Disease (CKD)
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
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.
Jean-Paul CRISTOL, Prof study director
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
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, run by University Hospital, Montpellier at 1 site in France.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 27 Apr 2022. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Paul CRISTOL, Prof (+33(0)4 67 33 83 15, jp-cristol@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of ionized magnesium levels before and after dialysis session (time frame: day 1). 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 27 Apr 2022.