NCT04700631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
143

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

January 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.5 years

First QC Date

January 6, 2021

Last Update Submit

September 16, 2025

Conditions

Chronic Renal FailureUrinary Extracellular Vesicle

Keywords

urinary extracellular vesicleChronic Renal Failure

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

healthy subject

ACTIVE COMPARATOR

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

Diagnostic Test: urinary extracellular vesicle concentrationDiagnostic Test: blood sample

CRF patients

EXPERIMENTAL

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

Diagnostic Test: urinary extracellular vesicle concentrationDiagnostic Test: blood sample

Interventions

urinary extracellular vesicle concentrationDIAGNOSTIC_TEST

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

CRF patientshealthy subject
blood sampleDIAGNOSTIC_TEST

blood sample in order to determine creatin level

CRF patientshealthy subject

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients under dialysis protocols
  • renal transplant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens

Amiens, 80480, France

Location

Related Publications (1)

  • Jacob V, de Berny Q, Brazier F, Presne C, Lion J, Ouled-Haddou H, Metzinger-Le Meuth V, Choukroun G, Metzinger L, Guillaume N. Quantification of Urine and Plasma Levels of Extracellular Vesicles in a Cohort of Kidney Transplant Recipients and Chronic Kidney Disease Patients. Int J Mol Sci. 2025 Apr 11;26(8):3635. doi: 10.3390/ijms26083635.

    PMID: 40332150RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2021

First Posted

January 8, 2021

Study Start

January 1, 2021

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)