Diuretic Testing in Chronic Kidney Disease

NCT ID: NCT06841692

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Disease, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diuretic Group

Administration of diuretics on the test day

Group Type EXPERIMENTAL

Diuretic Testing

Intervention Type DIAGNOSTIC_TEST

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

Time control group

No diuretics will be administered

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Diuretic Testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Research Council

OTHER

Sponsor Role collaborator

Erasmus Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ewout Hoorn

Prof.dr. E.J. Hoorn

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ewout J. Hoorn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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Erasmus MC

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Sebastian B Beckmann, MD

Role: CONTACT

+31 6 39022349

Facility Contacts

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Sebastian B. Beckmann, MD

Role: primary

+ 31 639022349

Madonna Salib, PhD, PharmD

Role: backup

+33 749172531

References

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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.

Reference Type BACKGROUND
PMID: 17699451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24053972 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11231365 (View on PubMed)

Other Identifiers

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101125504

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NL-005327

Identifier Type: OTHER

Identifier Source: secondary_id

NL87576.078.24

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2024-0799

Identifier Type: -

Identifier Source: org_study_id

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