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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRamsay Générale de Santé

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Hemodialysis adult patient

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood test

    Procedure/Surgery

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

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Hemodialysis patient1 intervention

Trial outcomes

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

Time frame
5 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ramsay Générale de Santé

Lead sponsor

European Clinical Trial Experts Network

Collaborator