Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Not Applicable

Completed

• Conditions: Urinary Extracellular Vesicle; Chronic Renal Failure
• Interventions: Diagnostic Test: urinary extracellular vesicle concentration; Diagnostic Test: blood sample

• Registration Number: NCT04700631
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-06
• Study First Posted: 2021-01-08
• Status Verified: 2023-07
• Primary Completion: 2023-07-01
• Study Completion: 2023-07-01
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
healthy subject	blood sample	healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
CRF patients	blood sample	CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²
healthy subject	urinary extracellular vesicle concentration	healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
CRF patients	urinary extracellular vesicle concentration	CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²

Primary Outcome Measures

Name	Time	Method
variation of urinary extracellular vesicle concentration between both groups	one day	variation of urinary extracellular vesicle concentration between both groups : healthy and CRF patients Urinary extracellular vesicle concentrations will be measured as number of extracellular vesicles per mL of urine

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France