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

• Sponsor: Ramsay Générale de Santé (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05586867
• Collaborator: European Clinical Trial Experts Network (Other)
• Enrollment: 200
• Location: 1
• Anticipated Duration (Months): 120
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Iron Metabolism Disorders; Calcium Phosphate Metabolism; Hepatic Metabolic Disorders; Hemodialysis Complication	Procedure: Blood test

Study Design

• Study Type: Observational
• Anticipated Enrollment: 200 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study of Markers of Iron Metabolism and Their Relationship With Phosphocalcic and Hepatic Metabolism and Inflammation in Hemodialysis Patients
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2026
• Anticipated Study Completion Date: Dec 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Hemodialysis patient	Procedure: Blood test; 15 mL of blood to follow the evolution of hepcidin and erythroferrone levels

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Privé Claude Galien	Quincy-sous-Sénart		France	91480

Sponsors and Collaborators

• Ramsay Générale de Santé
• European Clinical Trial Experts Network

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ramsay Générale de Santé
• ClinicalTrials.gov Identifier: NCT05586867
• Other Study ID Numbers: 2021-A01329-32
• First Posted: Oct 19, 2022
• Last Update Posted: Oct 19, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Metabolic Diseases; Iron Metabolism Disorders; Disease; Inflammation

Study Results

No Results Posted as of Oct 19, 2022