NCT06962891

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 213 (estimated)
• Sponsor: Angel Argiles · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease(CKD)
• Progression, Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CKD progression biomarker	We will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards.

Timeline

• Start date: 2023-05-02
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2025-05-08
• Last updated: 2025-07-24

Locations

3 sites across 3 countries: Austria, France, Germany