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

NCT06962891 | Active Not Recruiting

• 3 other identifiers: KidneySign Prospective Study20230529-32042024-A00107-40
• Study Type: observational
• Target: 213
• Locations: 3 countries
• Sites: 3

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.

Conditions

Chronic Kidney Disease(CKD); Progression, Disease

Outcome Measures

Primary Outcomes (1)

• Relative eGFR change

  Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula

  1 year

Secondary Outcomes (1)

• Major Adverse Renal Events (MARE)

  1 year

Study Arms (1)

CKD patients

adults with eGFR between 25 and 65 mL/min/1.73m²

Diagnostic Test: CKD progression biomarker

Interventions

CKD progression biomarker DIAGNOSTIC_TEST

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

CKD patients

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CKD patients attending nephrology medical visits

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Angel Argiles: lead
• Medical University Innsbruck: collaborator
• Klinikum Bayreuth GmbH: collaborator
• University of Skövde: collaborator
• RWTH Aachen University: collaborator
• RD Néphrologie SAS: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• University Paul Sabatier of Toulouse: collaborator

Study Sites (3)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

Néphrologie Dialyse St Guilhem

Sète, 34200, France

Location

Klinikum Bayreuth GmbH

Bayreuth, 95445, Germany

Location

Related Links

• Project website

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, spot urine, 24-hour collection urine

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Disease Progression

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angel Argiles

  RD Néphrologie, Néphrologie Dialyse St Guilhem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 2, 2023
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); DE (1); AU (1)