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

NCT05586867 | Recruiting

• 1 other identifier: 2021-A01329-32
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Metabolism Disorders; Calcium Phosphate Metabolism; Hepatic Metabolic Disorders; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Hemodialysis patient

Procedure: Blood test

Interventions

Blood test PROCEDURE

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

Hemodialysis patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hemodialysis adult patient

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

RECRUITING

MeSH Terms

Conditions

Iron Metabolism Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jeanfrancois.oudet@free.fr

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 19, 2022
• Study Start: December 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

FR (1)