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NCT04700631 Clinical Trial

Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Chronic Renal Failure Clinical Trial

— VE-IRC  

Official title:
Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04700631
Other study ID # PI2020_843_0104
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date July 1, 2023

Study information
Verified date July 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 143
Est. completion date July 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• urinary extracellular vesicle concentration
urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients
• blood sample
blood sample in order to determine creatin level

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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