Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05586867
Other study ID # 2021-A01329-32
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 1, 2031

Study information

Verified date October 2022
Source Ramsay Générale de Santé
Contact Jean-François Oudet
Phone 0683346567
Email jeanfrancois.oudet@free.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 1, 2031
Est. primary completion date December 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
Blood test
15 mL of blood to follow the evolution of hepcidin and erythroferrone levels

Locations

Country Name City State
France Hôpital Privé Claude Galien Quincy-sous-Sénart

Sponsors (2)

Lead Sponsor Collaborator
Ramsay Générale de Santé European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05980845 - The Effect Nature Sounds and Music on Hemodialysis Patients N/A
Recruiting NCT05020717 - Retrospective Survey of Hyperkalemia in Hemodialysis
Recruiting NCT04046042 - Virtual Reality Intradialysis: Last vs. First Part of the Session N/A
Recruiting NCT04094038 - The Effect of Intradialytic Parenteral Nutrition on Nutritional Status and Quality of Life in Hemodialysis Patients Phase 4
Completed NCT03311581 - The Feasibility of Propofol TCI in Hemodialysis Patients Undergoing Arteriovenous Shunt Surgery Phase 1
Completed NCT05531175 - REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS N/A
Completed NCT04057313 - Coffee in Hemodialysis and Headache N/A
Completed NCT03061552 - Inferior Vena Cava Sonography in Hemodialysis Patients and Quality of Life N/A
Completed NCT03251573 - The Cohort Study of Cognitive Impairment in Chinese Hemodialysis Patients
Completed NCT05568342 - The Effect of Roy Adaptation-Based Nursing Intervention N/A
Completed NCT03527680 - Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis N/A
Completed NCT04063423 - Non- Clinical Coagulation Activation During Hemodialysis
Active, not recruiting NCT06203795 - Dialysis Performance of the FX CorAL Membrane N/A
Completed NCT04319328 - Is Cefazolin, Ceftazidime and Ciprofloxacin Dosing Optimal in Hemodialysis Patients?
Completed NCT03627884 - Outcomes of the Use of Sodium Bicarbonate (8.4%) Solution as a Catheter Lock Solution to Prevent Hemodialysis Catheter Loss Due to Lumen Clot Formation Phase 4
Completed NCT05132036 - Lung Ultrasound Assessment of Fluid Overload in Haemodialysis Patients N/A
Completed NCT03076528 - An Innovative Virtually Supervised Exercise for Dialysis Patients Phase 2
Completed NCT06098443 - Acupressure Versus Transcutaneous Electrical Nerve Stimulation on Pain and Quality of Life Intradialysis N/A
Completed NCT04645121 - Carbon Monoxide-based Rebreathing Method and Bioimpedance in Hemodialysis Patients
Recruiting NCT04127877 - Bio Impedance-assisted Monitoring of Chronic Hemodialysis Patients N/A