Diuretic Testing in Chronic Kidney Disease

NCT06841692 | Recruiting

• 4 other identifiers: MEC-2024-0799101125504NL-005327NL87576.078.24
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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: 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

Keywords

Disease Progression; Diuretic Testing; Chronic Kidney Disease; Kidney Tubular Function

Outcome Measures

Primary Outcomes (1)

• 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)

  3 years

Study Arms (2)

Diuretic Group

EXPERIMENTAL

Administration of diuretics on the test day

Diagnostic Test: Diuretic Testing

Time control group

NO INTERVENTION

No diuretics will be administered

Interventions

Diuretic Testing DIAGNOSTIC_TEST

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

Diuretic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)
• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• European Research Council: collaborator

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

Related Publications (3)

• 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.

  PMID: 17699451 BACKGROUND

• 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.

  PMID: 24053972 BACKGROUND

• 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.

  PMID: 11231365 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Disease Progression

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ewout J. Hoorn, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sebastian B Beckmann, MD

CONTACT

+31 6 39022349; s.beckmann@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr. E.J. Hoorn

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)