Clinical Trial

Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease

Study acronym: KidneySign
Active, Not Recruiting
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Record status
This record was last updated July 24, 2025 (before its estimated March 1, 2026 completion). Its status may not reflect the trial's current state.
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. 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-30.
Trial Details
NCT Number NCT06962891
Lead Sponsor Angel Argiles
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
Conditions Chronic Kidney Disease(CKD), Progression, Disease
Enrollment 213 participants
Start Date 2023-05-02
Primary Completion 2026-03-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-24