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

NCT ID: NCT05586867

Last Updated: 2022-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2031-12-01

Brief Summary

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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

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Conditions

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Iron Metabolism Disorders Calcium Phosphate Metabolism Hepatic Metabolic Disorders Hemodialysis Complication

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodialysis patient

Blood test

Intervention Type PROCEDURE

15 mL of blood to follow the evolution of hepcidin and erythroferrone levels

Interventions

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Blood test

15 mL of blood to follow the evolution of hepcidin and erythroferrone levels

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Claude Galien

Quincy-sous-Sénart, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

0683346567

Marie-Hélène Barba

Role: CONTACT

Facility Contacts

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Guy ROSTOKER, Dr

Role: primary

06 03 00 42 91

Other Identifiers

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2021-A01329-32

Identifier Type: -

Identifier Source: org_study_id

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