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

NCT ID: NCT05122845

Last Updated: 2021-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-12

Study Completion Date

2019-05-23

Brief Summary

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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

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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.

Conditions

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Serum Bank Plasma Bank Dialysis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Healthy volunteers comparators to dialysis subjects

Creation of a biological collection for biological analysis

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé Claude Galien

Quincy-sous-Sénart, , France

Site Status

Countries

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France

Other Identifiers

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2018-A00040-55

Identifier Type: -

Identifier Source: org_study_id