Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-22 @ 3:10 AM
Study NCT ID:
NCT06841692
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2025-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diuretic Testing in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018450', 'term': 'Disease Progression'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 86}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-06', 'studyFirstSubmitDate': '2025-02-18', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression of Chronic Kidney Disease', 'timeFrame': '3 years', 'description': '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)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Disease Progression', 'Diuretic Testing', 'Chronic Kidney Disease', 'Kidney Tubular Function'], 'conditions': ['Kidney Disease, Chronic']}, 'referencesModule': {'references': [{'pmid': '17699451', 'type': 'BACKGROUND', 'citation': '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': '24053972', 'type': 'BACKGROUND', 'citation': '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': '11231365', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\nDoes a worse result of a diuretic test predict the progression of chronic kidney disease?\n\nIf 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.\n\nParticipants will undergo diuretic testing. This involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for CKD subjects:\n\n* CKD stage G3 (creatinine-based eGFR 30-59 mL/min/1.73m2) during the last outpatient visit\n\nInclusion Criteria for Healthy subjects:\n\n• 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\n\nExclusion Criteria:\n\n* Known intolerance or allergy to the diuretics\n* Current systemic chemotherapy for malignancy\n* Kidney transplant recipient\n* Use of calcineurin-inhibitors\n* Life expectancy \\< 12 months\n* Current immunosuppressive treatment for glomerulonephritis\n* Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team\n* Hypokalemia or hyperkalemia (K+ \\< 3.0mmol/L or K+ \\> 5.5 mmol/L) at inclusion visit\n* Hypo- or hypernatremia (Na+ \\< 130 mmol/L or Na+ \\> 150mmol/L) at inclusion visit\n* Inherited tubulopathy as the cause of CKD\n* Autosomal dominant polycystic or tubulointerstitial kidney disease causing CKD\n* Clinically relevant heart failure (New York Heart Association class III or IV)\n* Therapy-resistant hypertension, defined as systolic blood pressure \\> 180mmHg at the inclusion visit\n* Current treatment with inhibitors of Organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide \\[22\\]\n* Active hepatitis during last outpatient visit\n* Liver cirrhosis in advanced stage (Child-Pugh B or C)\n* Active drug- or alcohol abuse\n* Not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing.\n* Women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day'}, 'identificationModule': {'nctId': 'NCT06841692', 'acronym': 'U-TUBE 2', 'briefTitle': 'Diuretic Testing in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Erasmus Medical Center'}, 'officialTitle': 'Diuretic Testing in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'MEC-2024-0799'}, 'secondaryIdInfos': [{'id': '101125504', 'type': 'OTHER_GRANT', 'domain': 'European Research Council'}, {'id': 'NL-005327', 'type': 'OTHER', 'domain': 'Onderzoeksportaal'}, {'id': 'NL87576.078.24', 'type': 'OTHER', 'domain': 'Toetsing Online'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diuretic Group', 'description': 'Administration of diuretics on the test day', 'interventionNames': ['Diagnostic Test: Diuretic Testing']}, {'type': 'NO_INTERVENTION', 'label': 'Time control group', 'description': 'No diuretics will be administered'}], 'interventions': [{'name': 'Diuretic Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'The administration of hydrochlorothiazide and bumetanide is used to stimulate and assess tubular function.', 'armGroupLabels': ['Diuretic Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3015GD', 'city': 'Rotterdam', 'state': 'South Holland', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Sebastian B. Beckmann, MD', 'role': 'CONTACT', 'email': 's.beckmann@erasmusmc.nl', 'phone': '+ 31 639022349'}, {'name': 'Madonna Salib, PhD, PharmD', 'role': 'CONTACT', 'email': 'm.salib@erasmusmc.nl', 'phone': '+33 749172531'}, {'name': 'Ewout J. Hoorn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}], 'centralContacts': [{'name': 'Sebastian B Beckmann, MD', 'role': 'CONTACT', 'email': 's.beckmann@erasmusmc.nl', 'phone': '+31 6 39022349'}], 'overallOfficials': [{'name': 'Ewout J. Hoorn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Erasmus Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erasmus Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'European Research Council', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.dr. E.J. Hoorn', 'investigatorFullName': 'Ewout Hoorn', 'investigatorAffiliation': 'Erasmus Medical Center'}}}}