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NCT Number: NCT06732349

Urinary Tubular Biomarkers for Chronic Kidney Disease

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.

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Key information

Conditions

Chronic Kidney Disease Stage 3 Chronic Disease Disease Attributes Disease Progression Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Erasmus MC

Rotterdam, South Holland, 3015 GD, Netherlands

Location status: Recruiting

Location contact

Sebastian Beckmann, MD

CONTACT

[email protected]

+31639022349

About this study

Rationale Chronic kidney disease (CKD) is a common and progressive condition that affects over 800 million people worldwide and is now one of the leading causes of mortality. The kidney consists of filters and tubules, but diagnosis of progressive CKD is currently based on filter function alone (estimated glomerular filtration rate (eGFR) and albuminuria). However, it is tubular injury that drives CKD progression, and it is the tubule that is targeted by recently developed kidney-protective treatments. We hypothesize that a high-throughput tubular test panel, consisting of urine supersaturation and urinary extracellular vesicle (uEV) biomarkers, improves the prediction of CKD progression thereby enabling the early initiation of kidney-protective treatment.

Objective(s) To develop a high-throughput tubular test panel, consisting of urine supersaturation and uEV biomarkers, that improves the prediction of CKD progression.

Study type Prospective diagnostic trial.

Study population Adult patients with CKD stage G3 (eGFR 30-59 ml/min/1.73 m2).

Methods Urine samples are already collected as part of the standard of care and will be divided for measurement of albuminuria (standard of care) and urine supersaturation and uEV biomarkers (this project). The performance of the tubular test panel will be analyzed by comparing it to that of the existing Kidney Failure Risk Equation.

Burden and risks The diagnostic tests will be performed on a urine sample that is already collected as part of routine clinical care. Therefore, these diagnostic procedures do not pose an additional risk or burden.

Recruitment and consent Participants will be recruited from the Department of Internal Medicine outpatient clinics. For all study participants written informed consent will be obtained. The informed consent will include the approval (yes/no) to store samples for secondary use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

CKD Progression

Time frame: 3 years

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Madonna Salib, PhD

CONTACT

[email protected]

+33749172531

Sebastian Beckmann, MD

CONTACT

[email protected]

+31639022349

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Acronym: U-Tube 1

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Dec 13, 2024
Registry last updated: Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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