Diuretic Testing in Chronic Kidney Disease (U-TUBE 2)
August 6, 2025 updated by: Ewout Hoorn, Erasmus Medical Center
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sebastian B Beckmann, MD
- Phone Number: +31 6 39022349
- Email: s.beckmann@erasmusmc.nl
Study Locations
-
-
South Holland
-
Rotterdam, South Holland, Netherlands, 3015GD
- Recruiting
- Erasmus MC
-
Contact:
- Sebastian B. Beckmann, MD
- Phone Number: + 31 639022349
- Email: s.beckmann@erasmusmc.nl
-
Contact:
- Madonna Salib, PhD, PharmD
- Phone Number: +33 749172531
- Email: m.salib@erasmusmc.nl
-
Principal Investigator:
- Ewout J. Hoorn, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria for CKD subjects:
- CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit
Inclusion Criteria for Healthy subjects:
• 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
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diuretic Group
Administration of diuretics on the test day
|
The administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function.
|
|
No Intervention: Time control group
No diuretics will be administered
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ewout J. Hoorn, MD, PhD, Erasmus Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rodriguez-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.
- Chawla 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2025
Primary Completion (Estimated)
October 31, 2029
Study Completion (Estimated)
October 31, 2029
Study Registration Dates
First Submitted
February 18, 2025
First Submitted That Met QC Criteria
February 18, 2025
First Posted (Actual)
February 24, 2025
Study Record Updates
Last Update Posted (Actual)
August 7, 2025
Last Update Submitted That Met QC Criteria
August 6, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Kidney Diseases
- Renal Insufficiency, Chronic
- Physiological Effects of Drugs
- Natriuretic Agents
- Diuretics
Other Study ID Numbers
- MEC-2024-0799
- 101125504 (Other Grant/Funding Number: European Research Council)
- NL-005327 (Other Identifier: Onderzoeksportaal)
- NL87576.078.24 (Other Identifier: Toetsing Online)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.