Chronic Renal FailureVE-IRCNCT04700631
Extracellular Vesicles as Biomarkers for Chronic Renal Failure
A study testing urinary extracellular vesicle concentration and blood sample in people with Chronic Renal Failure and Urinary Extracellular Vesicle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Failure, Urinary Extracellular Vesicle
- What is being tested?
- urinary extracellular vesicle concentration and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients under dialysis protocols
- renal transplant patients
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- urinary extracellular vesicle concentration, blood sample
- Keywords
- urinary extracellular vesicle, Chronic Renal Failure
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urinary extracellular vesicle concentrationDiagnostic test
urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients
blood sampleDiagnostic test
blood sample in order to determine creatin level
| Study group | Role | What they receive |
|---|---|---|
| healthy subject | Active comparator | healthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI Receives: Diagnostic Test: urinary extracellular vesicle concentration; Diagnostic Test: blood sample |
| CRF patients | Experimental | CRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m² Receives: Diagnostic Test: urinary extracellular vesicle concentration; Diagnostic Test: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2021
- Study start1 Jan 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Renal FailureStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04700631
- Sponsor's protocol ID
- PI2020_843_0104
- Acronym
- VE-IRC
- Status last verified
- Sep 2025
- First submitted
- 6 Jan 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicles as Biomarkers for Chronic Renal Failure
- ClinicalTrials.gov ID
- NCT04700631
- Acronym / sponsor ID
- VE-IRC / PI2020_843_0104
- Keywords
- urinary extracellular vesicle, Chronic Renal Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 8 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy subject | Active comparator | Diagnostic Test: urinary extracellular vesicle concentration, Diagnostic Test: blood samplehealthy subjects : no medical history, in particular cardiovascular, without drug treatment, without proteinuria, normal BMI |
| CRF patients | Experimental | Diagnostic Test: urinary extracellular vesicle concentration, Diagnostic Test: blood sampleCRF patients : eGFR estimated according to the MRDR formula less than 89 mL/min/1,73m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- patients under dialysis protocols
- renal transplant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urinary extracellular vesicle concentrationurinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients | Diagnostic test | CRF patients, healthy subject |
| blood sampleblood sample in order to determine creatin level | Diagnostic test | CRF patients, healthy subject |
Primary outcome
variation of urinary extracellular vesicle concentration between both groups
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Results publication: PubMed 40332150Jacob 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urinary extracellular vesicle concentration and blood sample in people with Chronic Renal Failure and Urinary Extracellular Vesicle, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of urinary extracellular vesicle concentration between both groups (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04700631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.