Chronic Kidney Disease(CKD)KidneySignNCT06962891
Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease
An observational study of Chronic Kidney Disease(CKD) and Progression, Disease, run by Angel Argiles at 3 sites in 3 countries.
Trial summary
The goal of this longitudinal observational study is to estimate the performances of a candidate proteomic biomarker to identify patients at short term risk of chronic kidney disease (CKD) progression, in CKD patients attending nephrology visits in 3 participating centres. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Chronic Kidney Disease(CKD), Progression, Disease
- What is being tested?
- CKD progression biomarker
- How many people
- 213 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 2 May 2023to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CKD patients attending nephrology medical visits
Who may be able to join
- Male or female patients
- over 18 years and below 85 years of age at recruitment
- Chronic kidney disease (CKD)
- eGFR of 25-65 mL/min/1.73m2 (CKD-EPI formula)
- Beneficiary of health insurance
- Must be able to communicate with the investigator
- Written informed consent must be provided before participation.
Who cannot join
- History of renal transplantation
- Current episode of Acute Kidney Injury
- Any clinically significant disorder, which in the Investigator's opinion could interfere with the results of the trial.
- Known or suspected abuse of alcohol or narcotics
- Current pregnancy
- Inability to give written informed consent
- Protected adults
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
The goal of this longitudinal observational study is to estimate the performances of a candidate proteomic biomarker to identify patients at short term risk of chronic kidney disease (CKD) progression, in CKD patients attending nephrology visits in 3 participating centres. The primary endpoint of CKD progression is defined as a relative change in eGFR observed at 1 year below -10%. The performance of the candidate biomarker will be compared to performances of UAE and KFRE equations.
Participants will attend two study visits (baseline and 1-year), with clinical evaluation including kidney parameters (eGFR, urinary albumin excretion (UAE)) and collection of biological samples (plasma, serum, urine) for candidate proteomic biomarker evaluation. If planned in routine, patients will also have creatinine clearance estimation from 24-hour urine collection, kidney echography and kidney biopsy, sample biobanking and/or questionnaires and interviews on social and ethical aspects.
- Conditions
- Chronic Kidney Disease(CKD), Progression, Disease
- Being tested
- CKD progression biomarker
- Medical subject headings
- Renal Insufficiency, Chronic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD progression biomarkerDiagnostic test
We will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards.
| Study group | Role | What they receive |
|---|---|---|
| CKD patients | adults with eGFR between 25 and 65 mL/min/1.73m² Receives: Diagnostic Test: CKD progression biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative eGFR change
Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula
Measured: 1 year
Secondary outcomes (1)
Major Adverse Renal Events (MARE)
Composite endpoint defined by the occurrence of any of the following: worsening of kidney disease (-40% eGFR, doubling of creatinine), ESKD (dialysis therapy or renal transplantation), death of any cause.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start2 May 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease(CKD)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 213 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angel Argiles
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck, Klinikum Bayreuth GmbH, University of Skövde, RWTH Aachen University, RD Néphrologie SAS, Institut National de la Santé Et de la Recherche Médicale, France, University Paul Sabatier of Toulouse
- Responsible party
- Sponsor-investigator, Angel Argiles, RD Néphrologie SAS
- Investigators
- Angel Argiles, Principal investigator, RD Néphrologie, Néphrologie Dialyse St Guilhem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06962891
- Sponsor's protocol ID
- KidneySign Prospective Study
- Other IDs
- 20230529-3204, 2024-A00107-40
- Acronym
- KidneySign
- Status last verified
- Jul 2025
- First submitted
- 30 Apr 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06962891
- Acronym / sponsor ID
- KidneySign / KidneySign Prospective Study
- Conditions
- Chronic Kidney Disease(CKD), Progression, Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 213 participants (estimated)
- Lead sponsor
- Angel ArgilesIndustry (pharma, biotech, devices)
- Collaborators
- Medical University Innsbruck, Klinikum Bayreuth GmbH, University of Skövde, RWTH Aachen University, RD Néphrologie SAS, Institut National de la Santé Et de la Recherche Médicale, France, University Paul Sabatier of Toulouse
- Study start
- 2 May 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 May 2025 (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 goal of this longitudinal observational study is to estimate the performances of a candidate proteomic biomarker to identify patients at short term risk of chronic kidney disease (CKD) progression, in CKD patients attending nephrology visits in 3 participating centres. The primary endpoint of CKD progression is defined as a relative change in eGFR observed at 1 year below -10%. The performance of the candidate biomarker will be compared to performances of UAE and KFRE equations.
Participants will attend two study visits (baseline and 1-year), with clinical evaluation including kidney parameters (eGFR, urinary albumin excretion (UAE)) and collection of biological samples (plasma, serum, urine) for candidate proteomic biomarker evaluation. If planned in routine, patients will also have creatinine clearance estimation from 24-hour urine collection, kidney echography and kidney biopsy, sample biobanking and/or questionnaires and interviews on social and ethical aspects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD patients | – | Diagnostic Test: CKD progression biomarkeradults with eGFR between 25 and 65 mL/min/1.73m² |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CKD patients attending nephrology medical visits
Key inclusion criteria (7 listed)
- Male or female patients
- over 18 years and below 85 years of age at recruitment
- Chronic kidney disease (CKD)
- eGFR of 25-65 mL/min/1.73m2 (CKD-EPI formula)
- Beneficiary of health insurance
Key exclusion criteria (7 listed)
- History of renal transplantation
- Current episode of Acute Kidney Injury
- Any clinically significant disorder, which in the Investigator's opinion could interfere with the results of the trial.
- Known or suspected abuse of alcohol or narcotics
- Current pregnancy
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 |
|---|---|---|
| CKD progression biomarkerWe will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards. | Diagnostic test | CKD patients |
Primary outcome
Relative eGFR change
Time frame: 1 year
Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula
1 secondary outcome
Major Adverse Renal Events (MARE)
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Project websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Angel Argiles principal investigator
RD Néphrologie, Néphrologie Dialyse St Guilhem
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease(CKD) and Progression, Disease, run by Angel Argiles at 3 sites in 3 countries.
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 7 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, France, Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Relative eGFR change (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2025.