Urinary Tubular Biomarkers for Chronic Kidney Disease

NCT06732349 | Recruiting

• 1 other identifier: MEC-2024-0505 - U-Tube 1
• Study Type: observational
• Target: 556
• Locations: 1 country
• Sites: 1

Brief Summary

Currently used tests for chronic kidney injury only assess the function of one part of the kidney: the filter called the glomerulus. The other part, called the tubule, is disregarded. Based on many previous studies, the investigators have good reason to assume that a better prediction of the course of chronic kidney disease by testing tubular function will be possible. This is important, for example, when patients need to be treated with kidney-protecting drugs.

Conditions

Chronic Kidney Disease Stage 3

Keywords

biomarker; disease progression; chronic kidney disease; tubular function and injury; urine; risk assessment; personalized medicine

Outcome Measures

Primary Outcomes (1)

• CKD Progression

  Rate of participants that reach the composite of 30% reduction in estimated glomerular filtration rate (CKD-EPI creatinine-based) and/or the initiation of kidney replacement therapy (dialysis or kidney transplantation)

  3 years

Interventions

Urinary tubular test panel DIAGNOSTIC_TEST

The urinary tubular test panel will be applied to urine samples that are collected as part of the routine outpatient follow-up. Its predictive power for CKD progression will be assessed. The results of the tubular test panel will not influence the treatment of the patients. They will remain under standard outpatient treatment throughout the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≤18 years) with CKD stage 3, treated at the Internal Medicine outpatient department of the Erasmus MC university hospital (convenience sampling).

You may qualify if:

• Chronic kidney disease stage 3 (eGFR 30-59ml/min)

You may not qualify if:

• Active glomerulonephritis treated with immunosuppression
• Kidney transplant recipient
• Current treatment with chemo- or immunotherapy for malignancy

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Spot urine samples which are collected for routine clinical evaluation at the outpatient department

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Disease Progression; Wounds and Injuries

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Sebastian Beckmann, MD

CONTACT

+31639022349; s.beckmann@erasmusmc.nl

Madonna Salib, PhD

CONTACT

+33749172531; m.salib@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Nephrology, MD, PhD

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR, ANALYTIC CODE

Locations

NL (1)