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

Active, not recruiting

• Conditions: Chronic Kidney Disease(CKD); Progression, Disease

• Registration Number: NCT06962891
• Lead Sponsor: Angel Argiles

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.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-02
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Study First Posted: 2025-05-08
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-21
• Last Update Posted: 2025-07-24
• Primary Completion: 2026-03-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 213

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relative eGFR change	1 year	Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula

Secondary Outcome Measures

Name	Time	Method
Major Adverse Renal Events (MARE)	1 year	Composite endpoint defined by the occurrence of any of the following: worsening of kidney disease (-40% eGFR, doubling of creatinine), ESKD (dialysis therapy or renal transplantation), death of any cause.

Trial Locations

Locations (3)

Medizinische Universität Innsbruck; 🇦🇹 Innsbruck, Austria

Néphrologie Dialyse St Guilhem; 🇫🇷 Sète, France

Klinikum Bayreuth GmbH; 🇩🇪 Bayreuth, Germany