Iron Metabolism DisordersMARMEFENCT05586867
Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
An observational study of Iron Metabolism Disorders and Calcium Phosphate Metabolism, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Iron Metabolism Disorders, Calcium Phosphate Metabolism, Hepatic Metabolic Disorders
- What is being tested?
- Blood test
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2021to 1 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Hemodialysis adult patient
Who may be able to join
- Adult dialysis patient
- Patient able to understand the information necessary for the study and having signed his written consent to participate
- Affiliated patient or beneficiary of a social security scheme.
Who cannot join
- Medically unstable or frail patient
- Patient with hemoglobin less than 7g/dl
- Patient with HIV+ or AIDS, patient with replicating hepatitis B or C
- Patient participating in another clinical study requiring an additional blood sample
- Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision
- Pregnant, breastfeeding or parturient woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Claude Galien
Quincy-sous-Sénart, 91480
Guy ROSTOKER, Dr, 06 03 00 42 91, rostotom@orange.fr
About this study
From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.
The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.
The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.
- Conditions
- Iron Metabolism Disorders, Calcium Phosphate Metabolism, Hepatic Metabolic Disorders, Hemodialysis Complication
- Being tested
- Blood test
- Medical subject headings
- Iron Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testProcedure or surgery
15 mL of blood to follow the evolution of hepcidin and erythroferrone levels
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis patient | Not described Receives: Procedure: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).
These will be dosed twice over a year of dialysis and for 5 years
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Dec 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Metabolism DisordersStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586867
- Sponsor's protocol ID
- 2021-A01329-32
- Acronym
- MARMEFE
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05586867
- Acronym / sponsor ID
- MARMEFE / 2021-A01329-32
- Conditions
- Iron Metabolism Disorders, Calcium Phosphate Metabolism, Hepatic Metabolic Disorders, Hemodialysis Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2031 (estimated)
- First posted
- 19 Oct 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.
From a scientific point of view and for publication purposes, it therefore seems important to study the metabolism of iron and in particular to define its conditions of absorption, metabolism, elimination and storage in the body at course of advanced renal failure.
The study will follow the evolution of hormones regulating iron metabolism and put into perspective their links with phosphocalcic and hepatic metabolisms as well as inflammation in hemodialysis patients.
The main objective of this program is to study the evolution of hepcidin and erythroferrone levels in hemodialysis patients. These two biomarkers regulating iron metabolism are not performed routinely in dialysis centers and are not listed in the nomenclature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodialysis patient | – | Procedure: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hemodialysis adult patient
Key inclusion criteria (3 listed)
- Adult dialysis patient
- Patient able to understand the information necessary for the study and having signed his written consent to participate
- Affiliated patient or beneficiary of a social security scheme.
Key exclusion criteria (6 listed)
- Medically unstable or frail patient
- Patient with hemoglobin less than 7g/dl
- Patient with HIV+ or AIDS, patient with replicating hepatitis B or C
- Patient participating in another clinical study requiring an additional blood sample
- Patient benefiting from legal protection measures (guardianship, guardianship, etc.) adult under guardianship, guardianship or other legal protection, deprived of freedom by judicial or administrative decision
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 test15 mL of blood to follow the evolution of hepcidin and erythroferrone levels | Procedure or surgery | Hemodialysis patient |
Primary outcome
concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).
Time frame: 5 years
These will be dosed twice over a year of dialysis and for 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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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.
Marie-Hélène Barba contact
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 Iron Metabolism Disorders and Calcium Phosphate Metabolism, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 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: looking for participants now, as of the sponsor's last update on 19 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml). (time frame: 5 years). 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 19 Oct 2022.