Validation of a Proteomic Biomarker to Predict Progression of Chronic Kidney Disease (KidneySign)

Angel Argiles

Status: Active, not recruiting

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

Treatments: Diagnostic Test: CKD progression biomarker

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06962891

20230529-3204 (Registry Identifier)

2024-A00107-40 (Other Identifier)

KidneySign Prospective Study

Details and patient eligibility

About

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.

Pariticipants 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.

Enrollment: 213 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

213 participants in 1 patient group

CKD patients

Description:

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

Treatment:

Diagnostic Test: CKD progression biomarker