Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-31 @ 12:33 PM
Study NCT ID:
NCT04542304
Status:
TERMINATED
Last Update Posted:
2025-06-05
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy of Diuretics in Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008788', 'term': 'Metolazone'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D052999', 'term': 'Quinazolinones'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tsirich@stanford.edu', 'phone': '650-849-1907', 'title': 'Tammy Lisa Sirich, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination led to a small number of participants analyzed.'}}, 'adverseEventsModule': {'timeFrame': '4 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (single dose)', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Urine Output', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '809', 'spread': '466', 'groupId': 'OG000'}, {'value': '676', 'spread': '487', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline urine output at 1 week for each study arm', 'description': 'Average volume of urine produced in 24 hours.', 'unitOfMeasure': 'mL/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Clearance of Uremic Solutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'classes': [{'title': 'P-Cresol sulfate', 'categories': [{'measurements': [{'value': '15', 'spread': '11', 'groupId': 'OG000'}, {'value': '10', 'spread': '8', 'groupId': 'OG001'}]}]}, {'title': 'Indoxyl sulfate', 'categories': [{'measurements': [{'value': '34', 'spread': '20', 'groupId': 'OG000'}, {'value': '22', 'spread': '15', 'groupId': 'OG001'}]}]}, {'title': 'Hippurate', 'categories': [{'measurements': [{'value': '61', 'spread': '48', 'groupId': 'OG000'}, {'value': '42', 'spread': '29', 'groupId': 'OG001'}]}]}, {'title': 'Phenylactyl glutamine', 'categories': [{'measurements': [{'value': '14', 'spread': '9', 'groupId': 'OG000'}, {'value': '9', 'spread': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Kidney clearance of uremic solutes at 1 week for each study arm', 'description': 'Kidney clearance of uremic solutes in ml/min.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'timeFrame': 'Change from baseline quality of life score at 1 week for each study arm', 'description': 'Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the plan was to administer the intervention as a single dose, the investigators determined that the KDQOL should be removed from the study design because it is an evaluation used to assess changes over time. This decision was made prior to enrollment of any participants and was not administered to any study participants; however, the measure was not removed from the registration at that time.'}, {'type': 'SECONDARY', 'title': 'Plasma Urea', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '54', 'spread': '15', 'groupId': 'OG000'}, {'value': '54', 'spread': '13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'classes': [{'title': 'Systolic', 'categories': [{'measurements': [{'value': '140', 'spread': '25', 'groupId': 'OG000'}, {'value': '146', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic', 'categories': [{'measurements': [{'value': '77', 'spread': '13', 'groupId': 'OG000'}, {'value': '76', 'spread': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Metolazone', 'description': 'Metolazone (single dose)'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (single dose)'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '74', 'spread': '30', 'groupId': 'OG000'}, {'value': '73', 'spread': '31', 'groupId': 'OG001'}]}]}, {'title': 'Week 1', 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 1', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metolazone Then Placebo', 'description': 'Metolazone single dose taken orally during the first week, followed by washout of 1-2 weeks, then placebo single dose taken the following week.'}, {'id': 'FG001', 'title': 'Placebo Then Metolazone', 'description': 'Placebo single dose taken orally during the first week, followed by washout of 1-2 weeks, then metolazone single dose taken the following week.'}], 'periods': [{'title': 'Treatment Period 1 (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period (2 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2 (1 Week)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '17 participants signed informed consent, and 6 were randomized to treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Metolazone Then Placebo', 'description': 'Metolazone single dose taken orally during the first week, followed by washout of 1-2 weeks, then placebo single dose taken the following week.'}, {'id': 'BG001', 'title': 'Placebo Then Metolazone', 'description': 'Placebo single dose taken orally during the first week, followed by washout of 1-2 weeks, then metolazone single dose taken the following week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '66', 'spread': '13', 'groupId': 'BG001'}, {'value': '66', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 228563, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-04-17T16:56', 'hasProtocol': True}, {'date': '2025-04-14', 'size': 116719, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-14T19:13', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Lack of resources', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-16', 'studyFirstSubmitDate': '2020-08-27', 'resultsFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2020-09-08', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-16', 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Urine Output', 'timeFrame': 'Change from baseline urine output at 1 week for each study arm', 'description': 'Average volume of urine produced in 24 hours.'}], 'secondaryOutcomes': [{'measure': 'Kidney Clearance of Uremic Solutes', 'timeFrame': 'Kidney clearance of uremic solutes at 1 week for each study arm', 'description': 'Kidney clearance of uremic solutes in ml/min.'}, {'measure': 'Change in Quality of Life Questionnaire Score', 'timeFrame': 'Change from baseline quality of life score at 1 week for each study arm', 'description': 'Kidney Disease Quality of Life 36 Questionnaire (KDQOL36)'}, {'measure': 'Plasma Urea', 'timeFrame': 'Week 1'}, {'measure': 'Blood Pressure', 'timeFrame': 'Week 1'}, {'measure': 'Weight Change', 'timeFrame': 'Baseline, Week 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': 'This study will determine the efficacy of diuretics in patients with chronic kidney disease.', 'detailedDescription': 'Participants with chronic kidney disease will undergo two 1-week study periods (single-dose diuretic versus single-dose placebo) separated by 1-2 weeks of washout in a cross-over design. Blood and urine samples will be collected at the end of each study period to determine the effect on urine output and to assess the kidney clearance and levels of uremic solute. Participants will weigh themselves daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable chronic kidney disease patients able to provide consent\n* stable dialysis patients who produce urine and able to provide consent\n\nExclusion Criteria:\n\n* use of antibiotics for last two months or expected antibiotic use\n* recent hospitalization or other event resulting in instability of food intake'}, 'identificationModule': {'nctId': 'NCT04542304', 'briefTitle': 'Efficacy of Diuretics in Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Efficacy of Diuretics in Kidney Disease', 'orgStudyIdInfo': {'id': '56566'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metolazone then placebo', 'description': 'Metolazone will be taken orally during the first week, followed by washout of 1-2 weeks, then placebo will be taken the following week.', 'interventionNames': ['Drug: Metolazone', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo then Metolazone', 'description': 'Placebo will be taken orally during the first week, followed by washout of 1-2 weeks, then metolazone will be taken the following week.', 'interventionNames': ['Drug: Metolazone', 'Drug: Placebo']}], 'interventions': [{'name': 'Metolazone', 'type': 'DRUG', 'description': 'Participants receive a single dose of metolazone.', 'armGroupLabels': ['Metolazone then placebo', 'Placebo then Metolazone']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants receive a single dose of placebo to match metolazone.', 'armGroupLabels': ['Metolazone then placebo', 'Placebo then Metolazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'VA Palo Alto Health Care System', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine', 'investigatorFullName': 'Tammy Lisa Sirich', 'investigatorAffiliation': 'Stanford University'}}}}