Extracellular Vesicles as Biomarkers for Chronic Renal Failure

NCT ID: NCT04700631

Last Updated: 2025-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

143 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-07-01

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.

Detailed Description

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Conditions

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Chronic Renal Failure Urinary Extracellular Vesicle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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healthy subject

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

Group Type ACTIVE_COMPARATOR

urinary extracellular vesicle concentration

Intervention Type DIAGNOSTIC_TEST

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

blood sample

Intervention Type DIAGNOSTIC_TEST

blood sample in order to determine creatin level

CRF patients

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

Group Type EXPERIMENTAL

urinary extracellular vesicle concentration

Intervention Type DIAGNOSTIC_TEST

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

blood sample

Intervention Type DIAGNOSTIC_TEST

blood sample in order to determine creatin level

Interventions

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urinary extracellular vesicle concentration

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

Intervention Type DIAGNOSTIC_TEST

blood sample

blood sample in order to determine creatin level

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 40332150 (View on PubMed)

Other Identifiers

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PI2020_843_0104

Identifier Type: -

Identifier Source: org_study_id

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