Chronic Kidney Disease Stage 3U-Tube 1NCT06732349
Urinary Tubular Biomarkers for Chronic Kidney Disease
An observational study of Chronic Kidney Disease Stage 3, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease Stage 3
- What is being tested?
- Urinary tubular test panel
- How many people
- 556 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jan 2025to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Chronic kidney disease stage 3 (eGFR 30-59ml/min)
Who cannot join
- Active glomerulonephritis treated with immunosuppression
- Kidney transplant recipient
- Current treatment with chemo- or immunotherapy for malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015 GD
Sebastian Beckmann, MD, +31639022349, s.beckmann@erasmusmc.nl
About this study
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.
Read the detailed description
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.
- Conditions
- Chronic Kidney Disease Stage 3
- Being tested
- Urinary tubular test panel
- Keywords
- biomarker, disease progression, chronic kidney disease, tubular function and injury, urine, risk assessment, personalized medicine
- Medical subject headings
- Renal Insufficiency, Chronic, Disease Progression, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urinary tubular test panelDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Jan 2025
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease Stage 3Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ewout Hoorn, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732349
- Sponsor's protocol ID
- MEC-2024-0505 - U-Tube 1
- Acronym
- U-Tube 1
- Status last verified
- Aug 2025
- First submitted
- 10 Dec 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Tubular Biomarkers for Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06732349
- Acronym / sponsor ID
- U-Tube 1 / MEC-2024-0505 - U-Tube 1
- Conditions
- Chronic Kidney Disease Stage 3
- Keywords
- biomarker, disease progression, chronic kidney disease, tubular function and injury, urine, risk assessment, personalized medicine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Chronic kidney disease stage 3 (eGFR 30-59ml/min)
Key exclusion criteria (3 listed)
- Active glomerulonephritis treated with immunosuppression
- Kidney transplant recipient
- Current treatment with chemo- or immunotherapy for malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urinary tubular test panelThe 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. | Diagnostic test | – |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease Stage 3, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sebastian Beckmann, MD (+31639022349, s.beckmann@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CKD Progression (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.