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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medizinische Universität Innsbruck, Innsbruck, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CKD progression biomarker

Diagnostic Test

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

Primary outcomes

Relative eGFR change

Time frame: 1 year

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

Secondary outcomes

Major Adverse Renal Events (MARE)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Angel Argiles

Industry

Collaborators

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

Registry information

Acronym: KidneySign

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: May 8, 2025
Registry last updated: Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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