Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients (MARMEFE)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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-
-
Quincy-sous-Sénart, France, 91480
- Recruiting
- Hôpital Privé Claude Galien
-
Contact:
- Guy ROSTOKER, Dr
- Phone Number: 06 03 00 42 91
- Email: rostotom@orange.fr
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Hemodialysis patient
|
15 mL of blood to follow the evolution of hepcidin and erythroferrone levels
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A01329-32
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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