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ACTIVE NOT RECRUITING
NCT06962891

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

Sponsor: Angel Argiles

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

213

Start Date

2023-05-02

Completion Date

2026-05-01

Last Updated

2025-07-24

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

CKD progression biomarker

We will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards.

Locations (3)

Medizinische Universität Innsbruck

Innsbruck, Austria

Néphrologie Dialyse St Guilhem

Sète, France

Klinikum Bayreuth GmbH

Bayreuth, Germany