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

NCT06962891 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 213

Last updated 2025-07-24

No results posted yet for this study

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

DIAGNOSTIC_TEST

CKD progression biomarker

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

Sponsors & Collaborators

  • Medical University Innsbruck

    collaborator OTHER

  • Klinikum Bayreuth GmbH

    collaborator INDUSTRY

  • University of Skövde

    collaborator OTHER

  • RWTH Aachen University

    collaborator OTHER

  • RD Néphrologie SAS

    collaborator INDUSTRY

  • Institut National de la Santé Et de la Recherche Médicale, France

    collaborator OTHER_GOV

  • University Paul Sabatier of Toulouse

    collaborator OTHER

  • Angel Argiles

    lead INDUSTRY

Principal Investigators

  • Angel Argiles · RD Néphrologie, Néphrologie Dialyse St Guilhem

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-02
Primary Completion
2026-03-01
Completion
2026-05-01

Countries

  • Austria
  • France
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06962891 on ClinicalTrials.gov