Kidney Disease, ChronicU-TUBE 2NCT06841692
Diuretic Testing in Chronic Kidney Disease
A study testing Diuretic Testing in people with Kidney Disease, Chronic, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
The goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. The main questions it aims to answer are: Does a worse result of a diuretic test predict the progression of chronic kidney disease? If there is a comparison group… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- Diuretic Testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2025to 31 Oct 2029
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit
- eGFR within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function
Who cannot join
- Known intolerance or allergy to the diuretics
- Current systemic chemotherapy for malignancy
- Kidney transplant recipient
- Use of calcineurin-inhibitors
- Life expectancy < 12 months
- Current immunosuppressive treatment for glomerulonephritis
Show all 19Show fewer
- Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
- Hypokalemia or hyperkalemia (K+ < 3.0mmol/L or K+ > 5.5 mmol/L) at inclusion visit
- Hypo- or hypernatremia (Na+ < 130 mmol/L or Na+ > 150mmol/L) at inclusion visit
- Inherited tubulopathy as the cause of CKD
- Autosomal dominant polycystic or tubulointerstitial kidney disease causing CKD
- Clinically relevant heart failure (New York Heart Association class III or IV)
- Therapy-resistant hypertension, defined as systolic blood pressure > 180mmHg at the inclusion visit
- Current treatment with inhibitors of Organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide [22]
- Active hepatitis during last outpatient visit
- Liver cirrhosis in advanced stage (Child-Pugh B or C)
- Active drug- or alcohol abuse
- Not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing.
- Women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day
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, 3015GD
Sebastian B. Beckmann, MD, + 31 639022349, s.beckmann@erasmusmc.nl
Madonna Salib, PhD, PharmD, +33 749172531, m.salib@erasmusmc.nl
About this study
The goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. The main questions it aims to answer are:
Does a worse result of a diuretic test predict the progression of chronic kidney disease?
If there is a comparison group: Researchers will compare the diuretic test in patients with chronic kidney disease to healthy participants to see if the results are different in a healthy kidney.
Participants will undergo diuretic testing. This involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.
- Conditions
- Kidney Disease, Chronic
- Being tested
- Diuretic Testing
- Keywords
- Disease Progression, Diuretic Testing, Chronic Kidney Disease, Kidney Tubular Function
- Medical subject headings
- Renal Insufficiency, Chronic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diuretic TestingDiagnostic test
The administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function.
| Study group | Role | What they receive |
|---|---|---|
| Diuretic Group | Experimental | Administration of diuretics on the test day Receives: Diagnostic Test: Diuretic Testing |
| Time control group | No intervention | No diuretics will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of Chronic Kidney Disease
This composite outcome consists of the reduction of kidney function of 30% measured as creatinine-based estimated glomerular filtration rate (eGFR) using the chronic kidney disease epidemiology collaboration (CKD-EPI) 2021 formula 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 posted24 Feb 2025
- Study start1 Apr 2025
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney Disease, ChronicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- European Research Council
- Responsible party
- Principal investigator, Ewout Hoorn, Erasmus Medical Center
- Investigators
- Ewout J. Hoorn, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841692
- Sponsor's protocol ID
- MEC-2024-0799
- Other IDs
- 101125504, NL-005327, NL87576.078.24
- Acronym
- U-TUBE 2
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colussi G, Bettinelli A, Tedeschi S, De Ferrari ME, Syren ML, Borsa N, Mattiello C, Casari G, Bianchetti MG. A thiazide test for the diagnosis of renal tubular hypokalemic disorders. Clin J Am Soc Nephrol. 2007 May;2(3):454-60. doi: 10.2215/CJN.02950906. Epub 2007 Mar 14.
PubMed 17699451Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
PubMed 24053972Rodriguez-Iturbe B, Herrera J, Marin C, Manalich R. Tubular stress test detects subclinical reduction in renal functioning mass. Kidney Int. 2001 Mar;59(3):1094-102. doi: 10.1046/j.1523-1755.2001.0590031094.x.
PubMed 11231365
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
- Diuretic Testing in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06841692
- Acronym / sponsor ID
- U-TUBE 2 / MEC-2024-0799
- Conditions
- Kidney Disease, Chronic
- Keywords
- Disease Progression, Diuretic Testing, Chronic Kidney Disease, Kidney Tubular Function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- European Research Council
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 24 Feb 2025 (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.
The goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. The main questions it aims to answer are:
Does a worse result of a diuretic test predict the progression of chronic kidney disease?
If there is a comparison group: Researchers will compare the diuretic test in patients with chronic kidney disease to healthy participants to see if the results are different in a healthy kidney.
Participants will undergo diuretic testing. This involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diuretic Group | Experimental | Diagnostic Test: Diuretic TestingAdministration of diuretics on the test day |
| Time control group | No intervention | –No diuretics will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit
- eGFR within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function
Key exclusion criteria (19 listed)
- Known intolerance or allergy to the diuretics
- Current systemic chemotherapy for malignancy
- Kidney transplant recipient
- Use of calcineurin-inhibitors
- Life expectancy < 12 months
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 |
|---|---|---|
| Diuretic TestingThe administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function. | Diagnostic test | Diuretic Group |
Primary outcome
Progression of Chronic Kidney Disease
Time frame: 3 years
This composite outcome consists of the reduction of kidney function of 30% measured as creatinine-based estimated glomerular filtration rate (eGFR) using the chronic kidney disease epidemiology collaboration (CKD-EPI) 2021 formula 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.
- Background: PubMed 17699451Colussi G, Bettinelli A, Tedeschi S, De Ferrari ME, Syren ML, Borsa N, Mattiello C, Casari G, Bianchetti MG. A thiazide test for the diagnosis of renal tubular hypokalemic disorders. Clin J Am Soc Nephrol. 2007 May;2(3):454-60. doi: 10.2215/CJN.02950906. Epub 2007 Mar 14.
- Background: PubMed 24053972Chawla LS, Davison DL, Brasha-Mitchell E, Koyner JL, Arthur JM, Shaw AD, Tumlin JA, Trevino SA, Kimmel PL, Seneff MG. Development and standardization of a furosemide stress test to predict the severity of acute kidney injury. Crit Care. 2013 Sep 20;17(5):R207. doi: 10.1186/cc13015.
- Background: PubMed 11231365Rodriguez-Iturbe B, Herrera J, Marin C, Manalich R. Tubular stress test detects subclinical reduction in renal functioning mass. Kidney Int. 2001 Mar;59(3):1094-102. doi: 10.1046/j.1523-1755.2001.0590031094.x.
- Individual participant dataSharing planned: No
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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.
Ewout J. Hoorn, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diuretic Testing in people with Kidney Disease, Chronic, 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 2 inclusion and 19 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 B Beckmann, MD (+31 6 39022349, s.beckmann@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of Chronic Kidney Disease (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06841692, which also lists 3 linked publications.
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.