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

Recruiting

• Conditions: Hemodialysis Complication; Iron Metabolism Disorders; Calcium Phosphate Metabolism; Hepatic Metabolic Disorders
• Interventions: Procedure: Blood test

• Registration Number: NCT05586867
• Lead Sponsor: Ramsay Générale de Santé

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-19
• Last Update Posted: 2022-10-19
• Primary Completion: 2026-12-01
• Study Completion: 2031-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodialysis patient	Blood test	-

Primary Outcome Measures

Name	Time	Method
concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).	5 years	These will be dosed twice over a year of dialysis and for 5 years

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France