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NCT Number: NCT06841692

Diuretic Testing in Chronic Kidney Disease

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Diuretic Testing

Diagnostic Test

The administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function.

Primary outcomes

  1. 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)

Study contacts

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

Sebastian B Beckmann, MD

CONTACT

[email protected]

+31 6 39022349

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • European Research Council

Registry information

Acronym: U-TUBE 2

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 24, 2025
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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