Extracellular Vesicles as Biomarkers for Chronic Renal Failure (VE-IRC)

Centre Hospitalier Universitaire, Amiens

Status: Completed

Conditions: Chronic Renal Failure; Urinary Extracellular Vesicle

Treatments: Diagnostic Test: urinary extracellular vesicle concentration; Diagnostic Test: blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04700631

PI2020_843_0104

Details and patient eligibility

About

The recent discovery of extracellular vesicles (EV) as a mechanism of intercellular communication has made it possible to develop a new field of health research and could bring new information on the pathological mechanisms of renal diseases. Definition of physiologic and pathologic values of urinary extracellular vesicles (EVu) between healthy subjects and chronic kidney diseases (CKD) patients could be a new tool for follow up of renal diseases. EV are found in all biological fluids including urine, that's why they are increasingly analyzed in renal pathologies. The main objective of this study is to determine the physiological values and the pathological thresholds of EVu.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subject > 18 years old
• healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
• CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²

Exclusion criteria

• patients under dialysis protocols
• renal transplant patients

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

healthy subject

Active Comparator group

Description:

healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI

Treatment:

Diagnostic Test: blood sample

Diagnostic Test: urinary extracellular vesicle concentration

CRF patients

Experimental group

Description:

CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²

Treatment:

Diagnostic Test: blood sample

Diagnostic Test: urinary extracellular vesicle concentration