Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

Hemodialysis Complication Clinical Trial

— MARMEFE  

Official title:

Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05586867
• Other study ID #: 2021-A01329-32
• Status: Recruiting
• Start date: December 1, 2021
• Est. completion date: December 1, 2031

Study information

• Verified date: October 2022
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jeanfrancois.oudet[@]free.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2031
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Hemodialysis Complication
• Inflammation
• Iron Metabolism Disorders
• Metabolic Diseases

Intervention

Procedure:
• Blood test
15 mL of blood to follow the evolution of hepcidin and erythroferrone levels

Locations

Country	Name	City	State
France	Hôpital Privé Claude Galien	Quincy-sous-Sénart

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years