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NCT Number: NCT05586867

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

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.

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Key information

Conditions

Iron Metabolism Disorders Calcium Phosphate Metabolism Hemodialysis Complication Hepatic Metabolic Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Privé Claude Galien

Quincy-sous-Sénart, 91480, France

Location status: Recruiting

Location contact

Guy ROSTOKER, Dr

CONTACT

[email protected]

06 03 00 42 91

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Procedure

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

Primary outcomes

  1. concentration of the two main markers concerning iron metabolism: hepcidin (ng/ml) and erythroferone (ng/ml).

    Time frame: 5 years

    These will be dosed twice over a year of dialysis and for 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jean-François Oudet

CONTACT

[email protected]

0683346567

Marie-Hélène Barba

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Collaborators

  • European Clinical Trial Experts Network

Registry information

Acronym: MARMEFE

Important dates

Study start
2021
Primary completion
2026
Study completion
2031
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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