Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02975505
Status:
TERMINATED
Last Update Posted:
2025-02-17
First Post:
2016-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D006973', 'term': 'Hypertension'}], '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'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'elaine.ku@ucsf.edu', 'phone': '415-502-7760', 'title': 'Dr. Elaine Ku', 'organization': 'University of California, San Francisco Division of Nephrology'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Between baseline and year 4 of study', 'description': 'The study team collected adverse event information from the participants weekly.', 'eventGroups': [{'id': 'EG000', 'title': 'Strict SBP Target', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 18, 'seriousNumAtRisk': 66, 'deathsNumAffected': 5, 'seriousNumAffected': 30}, {'id': 'EG001', 'title': 'Usual SBP Target', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg', 'otherNumAtRisk': 42, 'deathsNumAtRisk': 42, 'otherNumAffected': 10, 'seriousNumAtRisk': 42, 'deathsNumAffected': 2, 'seriousNumAffected': 22}], 'otherEvents': [{'term': 'Acute kidney injury or ER visit', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 10}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'hospitalization'}], 'seriousEvents': [{'term': 'All-cause hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 30}, {'groupId': 'EG001', 'numAtRisk': 42, 'numAffected': 22}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'hospitalization'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Achieved Clinic Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Usual SBP Target', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}, {'id': 'OG001', 'title': 'Strict SBP Target', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)'}], 'classes': [{'categories': [{'measurements': [{'value': '138.2', 'spread': '5.3', 'groupId': 'OG000'}, {'value': '124.7', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At month 12', 'description': 'Achieved clinic SBP at month 12', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Difference in Clinic SBP Between the Two Arms', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Trial', 'description': 'Mean difference (less intensive - intensive)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '7.5', 'upperLimit': '16'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000'], 'paramType': 'beta', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.7', 'ciLowerLimit': '7.5', 'ciUpperLimit': '16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Months 4-12', 'description': 'Incorporating achieved mean SBP data between months 4-12', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Difference is measured between months 4-12'}, {'type': 'PRIMARY', 'title': 'Hyperkalemia, Syncope, Falls, ESKD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Strict SBP Control', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)'}, {'id': 'OG001', 'title': 'Usual SBP Control', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}], 'classes': [{'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Falls', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Dialysis or (re)-transplant', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 0-12', 'description': 'Potassium \\>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Screening to Enrollment Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '724', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Trial', 'description': 'Screening to enrollment ratio'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From baseline entry through the end of Year 3 of study', 'description': 'This is the number of potential participants screened as eligible to the number who agree to enroll', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Number of participants screened to enroll 1 participant'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Difference in Achieved SBP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Difference in Clinic SBP', 'description': 'Between month 4 and study end'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000', 'lowerLimit': '9', 'upperLimit': '16.1'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000'], 'paramType': 'beta', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.5', 'ciLowerLimit': '8', 'ciUpperLimit': '16', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Between month 4 after baseline and year 4 of study', 'description': 'Clinic', 'unitOfMeasure': 'mmHg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hyperkalemia, Syncope, Falls, ESKD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Strict SBP Control', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)'}, {'id': 'OG001', 'title': 'Usual SBP Control', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}], 'classes': [{'title': 'Hyperkalemia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Syncope', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Falls', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Dialysis or (re)-transplant', 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Between month 4 after baseline and year 4 of study', 'description': 'Potassium \\>=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Usual SBP Target', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}, {'id': 'FG001', 'title': 'Strict SBP Target', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'Month 4', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '61'}]}, {'type': 'COMPLETED', 'comment': 'Month 8', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '59'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '108', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Usual SBP Target', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}, {'id': 'BG001', 'title': 'Strict SBP Target', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg\n\nStrict blood pressure control: Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '70'}, {'value': '53', 'groupId': 'BG001', 'lowerLimit': '33', 'upperLimit': '62'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '38', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '93', '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/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian or Pacific Islander', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Native American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinic systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '135', 'groupId': 'BG000', 'lowerLimit': '125', 'upperLimit': '151'}, {'value': '135', 'groupId': 'BG001', 'lowerLimit': '120', 'upperLimit': '150'}, {'value': '135', 'groupId': 'BG002', 'lowerLimit': '124', 'upperLimit': '151'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Clinic diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '79', 'groupId': 'BG000', 'lowerLimit': '72', 'upperLimit': '85'}, {'value': '81', 'groupId': 'BG001', 'lowerLimit': '72', 'upperLimit': '87'}, {'value': '79', 'groupId': 'BG002', 'lowerLimit': '72', 'upperLimit': '86'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline eGFR', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000', 'lowerLimit': '17', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG001', 'lowerLimit': '19', 'upperLimit': '27'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '27'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mL/min/1.73 m2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Urine protein/creatinine ratio', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'g/g', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'History of heart failure', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of acute coronary syndrome', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of Smoking', 'classes': [{'title': 'Never', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}]}, {'title': 'Former', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Current', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance', 'classes': [{'title': 'Medicare', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}, {'title': 'Medicaid', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Private', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-02-13', 'size': 215869, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-13T15:43', 'hasProtocol': True}, {'date': '2025-02-13', 'size': 104274, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-13T15:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}}, 'statusModule': {'whyStopped': 'Due to challenges in recruitment and visits during COVID', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2021-07-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2016-11-22', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2016-11-28', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-13', 'studyFirstPostDateStruct': {'date': '2016-11-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Difference in Achieved SBP', 'timeFrame': 'Between month 4 after baseline and year 4 of study', 'description': 'Clinic'}, {'measure': 'Hyperkalemia, Syncope, Falls, ESKD', 'timeFrame': 'Between month 4 after baseline and year 4 of study', 'description': 'Potassium \\>=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation'}], 'primaryOutcomes': [{'measure': 'Achieved Clinic Systolic Blood Pressure', 'timeFrame': 'At month 12', 'description': 'Achieved clinic SBP at month 12'}, {'measure': 'Difference in Clinic SBP Between the Two Arms', 'timeFrame': 'Months 4-12', 'description': 'Incorporating achieved mean SBP data between months 4-12'}, {'measure': 'Hyperkalemia, Syncope, Falls, ESKD', 'timeFrame': 'Months 0-12', 'description': 'Potassium \\>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization'}], 'secondaryOutcomes': [{'measure': 'Screening to Enrollment Ratio', 'timeFrame': 'From baseline entry through the end of Year 3 of study', 'description': 'This is the number of potential participants screened as eligible to the number who agree to enroll'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Disease', 'Bloodpressure', 'Hypertension']}, 'referencesModule': {'references': [{'pmid': '39427725', 'type': 'DERIVED', 'citation': 'Ku E, Copeland TP, McCulloch CE, Seth D, Carlos CA, Cho K, Malkina A, Lo LJ, Hsu RK. Intensive Home Blood Pressure Lowering in Patients With Advanced CKD. Am J Kidney Dis. 2025 Mar;85(3):320-328. doi: 10.1053/j.ajkd.2024.08.010. Epub 2024 Oct 18.'}]}, 'descriptionModule': {'briefSummary': 'The transition from chronic kidney disease (CKD) to end-stage renal disease ESRD is a vulnerable and challenging period of time for patients and providers. Suboptimal control of blood pressure is known to be common in patients with the advanced stages of CKD, and may contribute to their elevated risk of progression to ESRD, cardiovascular morbidity, and mortality. This proposal is a pilot randomized controlled trial designed to test whether intensive home blood pressure lowering is feasible and safe in patients with advanced CKD as they transition to ESRD.', 'detailedDescription': 'The transition from advanced chronic kidney disease (CKD), when estimated glomerular filtration rate (eGFR) is \\<=30 mL/min/1.73m2, to end-stage renal disease (ESRD) represents a vulnerable period, when multiple physiologic and psychosocial changes occur as patients prepare for either dialysis or kidney transplant. This study is a pilot randomized controlled trial to test the safety and feasibility of studying strict versus usual BP control in a population of patients with advanced CKD (eGFR \\<=30 mL/min/1.73m2), including those with diabetes. For this pilot study, we will randomize 120 patients with advanced CKD who have elevated BP to either a home SBP target of \\<120 mm Hg (intervention group) versus usual care (130-140 mmHg).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults ≥16 years of age who meet the eGFR eligibility criteria, which will be determined based on whether participants have\n\n1. at least two eGFR in the last three months that are \\<=30 mL/min/1.73m2 or\n2. prior diagnosis of CKD (per electronic chart review) and at least one eGFR \\<=30 mL/min/1.73m2\n3. history of hypertension\n4. mid-arm circumference between 22-37cm (BP cuff size limitation) and be able to provide consent to participate in our study.\n\nExclusion criteria\n\nThose who:\n\n* are or are planning to become pregnant, due to inability to take multiple classes of anti-hypertensive agents\n* are marginally housed, due to concerns regarding routine follow-up\n* are actively participating in a different interventional trial that may affect blood pressure\n* are unwilling to consent to participate\n* institutionalized individuals or prisoners\n* are actively abusing illicit drugs or alcohol\n* have a history of poor or doubtful compliance (e.g., frequently missed appointments)\n* have office SBP \\>170 mmHg\n* are already taking \\>5 anti-hypertensive medications (any classes, including diuretics) have cognitive impairment prohibiting participation in the study.'}, 'identificationModule': {'nctId': 'NCT02975505', 'acronym': 'PERFORMANCE', 'briefTitle': 'Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD', 'orgStudyIdInfo': {'id': '16-20978'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Strict SBP Target', 'description': 'Target Systolic Home Blood Pressure \\<120 mm Hg', 'interventionNames': ['Other: Strict blood pressure control']}, {'type': 'NO_INTERVENTION', 'label': 'Usual SBP Target', 'description': 'Target Systolic Home Blood Pressure 130-140 mm Hg'}], 'interventions': [{'name': 'Strict blood pressure control', 'type': 'OTHER', 'description': 'Systolic Blood Pressure Target \\< 120 mm Hg (measured at home)', 'armGroupLabels': ['Strict SBP Target']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Raymond Hsu, MD MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Elaine Ku, MD MAS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}