Constitutive Study of a Serum Bank and Plasma Bank of Healthy Subjects Comparators to Dialysis Subjects (SPSSCD)

Not Applicable

Completed

• Conditions: Dialysis; Serum Bank; Plasma Bank
• Interventions: Biological: Blood sample

• Registration Number: NCT05122845
• Lead Sponsor: Ramsay Générale de Santé

Brief Summary

To be able to evaluate the predictive value of glycosylated ferritin as a predictive marker of hepatic iron stock in dialysis patients, we need to validate these results with a cohort of healthy volunteers.

Detailed Description

This biological collection will include a sample of 2 dry tubes and 2 EDTA tubes. A haematological assessment (CBC, platelets, reticulocytes, Chr (hemoglobin content of reticulocytes), TP-INR, AST, ALT, GGT), measurement of biological markers of iron metabolism (ferritin, serum iron, CRP, transferrin, soluble receptors transferrin, transferrin saturation coefficient) as well as a creatinine assay to validate the normality of renal function in healthy volunteers (GFR established from the MDRD formula), a complete ionogram and a phosphocalcic balance being given the interactions in the dialysis patient (but also in normal subjects) between iron metabolism and phosphocalcic metabolism (calcemia, phosphoremia, PTH, 25OHD3, 1,25OH2D3) will be performed.

We will also study the links between iron overload in dialysis patients and the modulation of the synthesis of parathyroid hormone (intact PTH), FGF23, alpha Klotho and sclerostin.

Study Timeline

• Study Start: 2019-04-12
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-23
• Study First Submitted: 2021-10-19
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-16
• Last Update Submitted: 2021-11-16
• Study First Posted: 2021-11-17
• Last Update Posted: 2021-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Informed consent
• Age over 18 years old
• Healthy volunteers
• Having given their informed consent in writing
• Absence of current pathology
• No current treatment (except contraception)

Exclusion Criteria

• Refusal of consent or absence of signature
• Minor, subject protected by law, (guardianship or curatorship, administrative protection measure)
• Pregnant woman, parturient
• Subject suffering from a condition liable to modify his blood parameters

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers comparators to dialysis subjects	Blood sample	Creation of a biological collection for biological analysis

Primary Outcome Measures

Name	Time	Method
Number of participant with a serum and plasma bank creation	one day	it is only a serum and plasma bank constitution

Trial Locations

Locations (1)

Hôpital Privé Claude Galien; 🇫🇷 Quincy-sous-Sénart, France