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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

213 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-02

Study Completion Date

2026-05-01

Brief Summary

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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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Detailed Description

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Conditions

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Chronic Kidney Disease(CKD) Progression, Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CKD patients

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

CKD progression biomarker

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CKD progression biomarker

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No