Clinical trial NCT06962891: Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease
Official title: Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Kidney Disease(CKD)
Progression, Disease
Lead sponsor: RD Néphrologie SAS
Sponsor class: INDUSTRY
Collaborators: name: Medical University Innsbruck
name: Klinikum Bayreuth GmbH
name: University of Skövde
name: RWTH Aachen University
name: RD Néphrologie SAS
name: Institut National de la Santé Et de la Recherche Médicale, France
name: University Paul Sabatier of Toulouse
First posted: 2025-05-08
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CKD patients attending nephrology medical visits

Brief 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. 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.

Pariticipants 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Relative eGFR change
timeFrame: 1 year
Secondary outcomes:
measure: Major Adverse Renal Events (MARE)
timeFrame: 1 year
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Sète
country: France
facility: Néphrologie Dialyse St Guilhem
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth GmbH
Study officials:
affiliation: RD Néphrologie, Néphrologie Dialyse St Guilhem
name: Angel Argiles
role: PRINCIPAL_INVESTIGATOR
References: