VE-IRC: Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT04700631

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Renal Failure Urinary Extracellular Vesicle	Diagnostic Test: urinary extracellular vesicle concentration Diagnostic Test: blood sample	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Extracellular Vesicles as Biomarkers for Chronic Renal Failure

Actual Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: healthy subject

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

Diagnostic Test: urinary extracellular vesicle concentration

urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients

Diagnostic Test: blood sample

blood sample in order to determine creatin level

Experimental: CRF patients

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

Diagnostic Test: urinary extracellular vesicle concentration

urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients

Diagnostic Test: blood sample

blood sample in order to determine creatin level

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens	Amiens		France	80480

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT04700631

Other Study ID Numbers:

PI2020_843_0104

First Posted:

Jan 8, 2021

Last Update Posted:

Jul 21, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire, Amiens

urinary extracellular vesicle

Chronic Renal Failure

Additional relevant MeSH terms:

Renal Insufficiency

Kidney Failure, Chronic

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Jul 21, 2021