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

Primary Purpose

Chronic Renal Failure, Urinary Extracellular Vesicle

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
urinary extracellular vesicle concentration
blood sample
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Renal Failure focused on measuring urinary extracellular vesicle, Chronic Renal Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

healthy subject

CRF patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 6, 2021
Last Updated
July 18, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04700631
Brief Title
Extracellular Vesicles as Biomarkers for Chronic Renal Failure
Acronym
VE-IRC
Official Title
Extracellular Vesicles as Biomarkers for Chronic Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Renal Failure, Urinary Extracellular Vesicle
Keywords
urinary extracellular vesicle, Chronic Renal Failure

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
healthy subject
Arm Type
Active Comparator
Arm Description
healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI
Arm Title
CRF patients
Arm Type
Experimental
Arm Description
CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m²
Intervention Type
Diagnostic Test
Intervention Name(s)
urinary extracellular vesicle concentration
Intervention Description
urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients
Intervention Type
Diagnostic Test
Intervention Name(s)
blood sample
Intervention Description
blood sample in order to determine creatin level
Primary Outcome Measure Information:
Title
variation of urinary extracellular vesicle concentration between both groups
Description
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
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Extracellular Vesicles as Biomarkers for Chronic Renal Failure

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