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RecruitingNCT05586867MARMEFEUpdated Oct 19, 2022

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

An observational study in Iron Metabolism Disorders, Calcium Phosphate Metabolism and Hepatic Metabolic Disorders, sponsored by Ramsay Générale de Santé. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Ramsay Générale de Santé · Observational

From the registry’s dates

  • Started Dec 2021; still recruiting 4 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Iron Metabolism Disorders
  • Calcium Phosphate Metabolism
  • Hepatic Metabolic Disorders
  • Hemodialysis Complication
03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 200 is above the median of 176 across 300 observational studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Ramsay Générale de Santé is the lead sponsor of 42 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Hemodialysis adult patient

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • Hemodialysis patient

    Procedure: Blood test

Interventions

  • ProcedureBlood test

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • Hôpital Privé Claude Galien
    Quincy-sous-Sénart, 91480, France
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05586867
Lead sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
Responsible party
Sponsor
First posted
Oct 19, 2022
Start date
Dec 1, 2021
Primary completion
Dec 1, 2026 (estimated)
Completion
Dec 1, 2031 (estimated)
Last update
Oct 19, 2022

Study contacts

Jean-François Oudet
Contact
jeanfrancois.oudet@free.fr
0683346567
Marie-Hélène Barba
Contact
mh.barba@ecten.eu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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