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

Dialysis Clinical Trial

— SPSSCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05122845
• Other study ID #: 2018-A00040-55
• Status: Completed
• Phase: N/A
• Start date: April 12, 2019
• Est. completion date: May 23, 2019

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 23, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dialysis

Intervention

Biological:
• Blood sample
Blood test (10 tubes of 5mL) : - 6 tubes for : complete blood count, platelets, reticulocyte count, TP-INR, AST, ALT, GGT ferritin, serum iron, CRP, transferrin, soluble transferrin receptors, transferrin saturation coefficient enzymatic creatinine, MDRD, ionogram calcemia, phosphoremia, PTH, 25 (OH) D3, 1.25 (OH) 2D3. 2 dry tubes 2 tube EDTA

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