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NCT06962891Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Jul 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
213 (estimated)
First submitted
30 Apr 2025
Start date
May 2023
Primary completion date
Mar 2026
Lead sponsor
Angel Argiles
NCT number
NCT06962891

What you commit to

  • Study type: Observational
  • Planned participants: 213
  • From May 2023 to the primary completion date, Mar 2026
  • 3 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of renal transplantation
  • Any clinically significant disorder, which in the Investigator's opinion could interfere with the results of the trial.

Other

  • Current episode of Acute Kidney Injury
  • Known or suspected abuse of alcohol or narcotics
  • Current pregnancy
  • Inability to give written informed consent
  • Protected adults

Who the study is looking for

  • 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.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Medizinische Universität Innsbruck
Coordinator of this site? Confirm its status
InnsbruckAustriaUnknown status
Klinikum Bayreuth GmbH
Coordinator of this site? Confirm its status
BayreuthGermanyUnknown status
Néphrologie Dialyse St Guilhem
Coordinator of this site? Confirm its status
SèteFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.