Chronic Kidney Disease(CKD), Progression, Disease
Conditions
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.
Interventions
DIAGNOSTIC_TESTCKD progression biomarker
We will evaluate the CKD progression biomarker at baseline and evaluate 1-year CKD progression afterwards.
Sponsors
Medical University Innsbruck
Klinikum Bayreuth GmbH
University of Skövde
RWTH Aachen University
RD Néphrologie SAS
Institut National de la Santé Et de la Recherche Médicale, France
University Paul Sabatier of Toulouse
Angel Argiles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative eGFR change | 1 year | Difference in eGFR after 1-year divided by baseline eGFR estimated with CKD-EPI formula |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Austria, France, Germany
Outcome results
None listed