Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-04-11 @ 2:39 PM
Study NCT ID:
NCT01750294
Status:
COMPLETED
Last Update Posted:
2016-06-13
First Post:
2012-12-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002752', 'term': 'Chlorthalidone'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001577', 'term': 'Benzophenones'}, {'id': 'D010797', 'term': 'Phthalimides'}, {'id': 'D007094', 'term': 'Imides'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D054833', 'term': 'Isoindoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ragarwal@iu.edu', 'phone': '317-988-2241', 'title': 'Rajiv Agarwal, MD, FAHA, FASN, FASH', 'organization': 'Indiana University & Richard L Roudebush VA Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline (week 0) through study completion (week 12)', 'eventGroups': [{'id': 'EG000', 'title': 'Chlorthalidone', 'description': 'Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)', 'otherNumAtRisk': 14, 'otherNumAffected': 7, 'seriousNumAtRisk': 14, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperuricemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Transient elevations of serum creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}], 'seriousEvents': [{'term': 'Elective kidney biopsy', 'notes': 'Subject experienced a drop in hemoglobin following an elective kidney biopsy and was admitted for concern of internal bleeding, which was absent on a computerized tomography (CT) scan.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'New-onset ischemic stroke', 'notes': 'Occurred in a subject with a history of strokes, seizures, and co-morbid diabetes mellitus who volitionally stopped all anti-hypertensive medications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hypotension', 'notes': 'Occurred in a subject with a history of strokes, seizures, and co-morbid diabetes mellitus who volitionally stopped all anti-hypertensive medications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Syncope', 'notes': 'Occurred in a subject with a history of strokes, seizures, and co-morbid diabetes mellitus who volitionally stopped all anti-hypertensive medications.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Chlorthalidone', 'description': 'Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.5', 'spread': '4.2', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000'], 'pValueComment': 'a = 0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 12 weeks after intervention', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat analysis (includes completers and non-completers)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Chlorthalidone', 'description': 'Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Safety Endpoint', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Subjects were recruited from the VA Medical Center from Sept. 18, 2012 - May 15, 2013. Eligible subjects were ≥ 18 years of age with estimated glomerular filtration rate ≤ 45 but \\> 20 mL/min/1.73m2. The study initially recruited subjects with resistant hypertension but was amended to include those with poorly controlled but treated hypertension.', 'preAssignmentDetails': 'Prior to assignment, participants completed home blood pressure monitoring, ambulatory blood pressure monitoring, and a two-week run-in period, during which all subjects received a standard anti-hypertensive regimen based on the existing regimen of the subject.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Chlorthalidone', 'description': 'Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '10.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Kidney Disease (CKD) Stage', 'classes': [{'title': 'Stage 3B', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Stage 4', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': 'Stage 5', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Staging captured according to estimated glomerular filtration rate (eGFR) at baseline using the National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines for staging chronic kidney disease (CKD).', 'unitOfMeasure': 'participants'}, {'title': 'Estimated GFR', 'classes': [{'categories': [{'measurements': [{'value': '26.8', 'spread': '8.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Measured after two-week run-in', 'unitOfMeasure': 'mL/min/1.73m2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Participants who completed the two-week run-in and enrolled in the study are included in the baseline analysis.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-10', 'studyFirstSubmitDate': '2012-12-12', 'resultsFirstSubmitDate': '2016-04-06', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2016-06-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-04-06', 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-05-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Systolic Ambulatory Blood Pressure From Baseline to 12 Weeks', 'timeFrame': 'Baseline and 12 weeks after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hypertension', 'kidney disease'], 'conditions': ['Chronic Kidney Disease', 'Poorly-Controlled Hypertension']}, 'descriptionModule': {'briefSummary': 'It is estimated that in the United States there are approximately 8 million individuals with moderate to severe chronic kidney disease (CKD), not on dialysis. Volume expansion plays an important role in the pathogenesis of hypertension in patients with CKD. For this pilot study, the investigators hypothesize that administration of chlorthalidone among patients with moderate to severe CKD will improve blood pressure (BP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age greater than 18 years.\n* Estimated glomerular filtration rate (eGFR) ≤ 45 ml/min/1.73m2 but ≥20 mL/min/1.73m2.\n* Poorly controlled blood pressure by 24-hour ambulatory blood pressure (BP) monitoring.\n* Treated hypertension: use of at least one antihypertensive drug. One of the drugs should be either an angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB). If these are contraindicated then use of a beta-blocker is required.\n\nExclusion Criteria:\n\n* Use of thiazide or thiazide-like drugs in the previous 3 months.\n* Use of furosemide in a dose \\>200 mg/d.\n* Ambulatory BP of either ≥160 systolic or ≥100 mmHg by 24-hour ambulatory BP monitoring.\n* Expected to receive renal replacement therapy within the next 3 months.\n* Vascular event such as myocardial infarction, heart failure hospitalization, or stroke within 3 months prior to randomization.\n* Pregnant or breastfeeding women or women who are planning to become pregnant or those not using a reliable form of contraception (oral contraceptives. condoms and diaphragms will be considered reliable).\n* Known hypersensitivity to thiazide or sulfa drugs.\n* Organ transplant recipient or therapy with immunosuppressive agents. Nasal or inhaled corticosteroids will be permitted.'}, 'identificationModule': {'nctId': 'NCT01750294', 'briefTitle': 'A Pilot Study of Chlorthalidone Among Patients With Poorly Controlled Hypertension and CKD', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'orgStudyIdInfo': {'id': '1206009002'}, 'secondaryIdInfos': [{'id': '1206009002', 'type': 'OTHER', 'domain': 'IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Chlorthalidone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Richard L. Roudebush VAMC', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Rajiv Agarwal, MD FASN FAHA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}