CClinicalTrials.gg
CompletedNCT04700631VE-IRCUpdated Sep 19, 2025

Extracellular Vesicles as Biomarkers for Chronic Renal Failure

An interventional study of urinary extracellular vesicle concentration and blood sample in Chronic Renal Failure and Urinary Extracellular Vesicle, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
143
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Renal Failure
  • Urinary Extracellular Vesicle

Keywords

  • urinary extracellular vesicle
  • Chronic Renal Failure
03

In context

Kidney Failure, Chronic

2,085 studies on the registry are indexed under Kidney Failure, Chronic; 260 are open to participants now.

This study's enrollment of 143 is above the median of 55 across 1,557 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 576 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients under dialysis protocols
  • renal transplant patients
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
143 participants (actual)

Study arms

  • 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 · Diagnostic Test: blood sample

  • 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 · Diagnostic Test: blood sample

Interventions

  • Diagnostic testurinary extracellular vesicle concentration

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

  • Diagnostic testblood sample

    blood sample in order to determine creatin level

06

What researchers measure

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

    Time frame: one day

07

Study locations

1 site
  • CHU Amiens
    Amiens, 80480, France
08

References and documents

Publications

  • 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. PubMed 40332150 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04700631
Lead sponsor
Centre Hospitalier Universitaire, Amiens
Responsible party
Sponsor
First posted
Jan 8, 2021
Start date
Jan 1, 2021
Primary completion
Jul 1, 2023
Completion
Jul 1, 2023
Last update
Sep 19, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion