Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Study Overview
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Brief Summary
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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.

Official Title
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Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Conditions
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Chronic Renal Failure, Urinary Extracellular Vesicle

Intervention / Treatment
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* Diagnostic Test: urinary extracellular vesicle concentration
* Diagnostic Test: blood sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: healthy subject<br>healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI | Diagnostic Test: urinary extracellular vesicle concentration<br>* urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients<br>Diagnostic Test: blood sample<br>* blood sample in order to determine creatin level<br>|
| Experimental: CRF patients<br>CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m² | Diagnostic Test: urinary extracellular vesicle concentration<br>* urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients<br>Diagnostic Test: blood sample<br>* blood sample in order to determine creatin level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of urinary extracellular vesicle concentration between both groups | 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 | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary extracellular vesicle, Chronic Renal Failure