Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 8:04 AM
Study NCT ID:
NCT04051957
Status:
TERMINATED
Last Update Posted:
2022-08-03
First Post:
2019-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Sponsor:
Organization:
Raw JSON
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[{'id': 'C030397', 'term': 'isosorbide-5-mononitrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jaya.kala@uth.tmc.edu', 'phone': '713-500-6868', 'title': 'Jaya Kala, MD', 'organization': 'The University of Texas Health Science Center at Houston'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Early termination due to the COVID pandemic and limited clinical face-to-face appointments leading to small numbers of subjects analyzed.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 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'timeFrame': 'Baseline, Month 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 2 in the Isosorbide Mononitrate arm.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 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[{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 2', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of 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Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 5', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 6', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 7', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 8', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 2 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 9', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 10', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 11', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 3 in the Isosorbide Mononitrate arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected for 2 in the Isosorbide Mononitrate arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Isosorbide Mononitrate', 'description': 'Isosorbide Mononitrate: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo oral tablet: Placebo will be given daily and will be doubled after 4 weeks of start of therapy.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2019-10-24', 'size': 808616, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-07-28T18:54', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Delays due to COVID and loss of research coordinator.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'dispFirstSubmitDate': '2021-06-23', 'completionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-02', 'studyFirstSubmitDate': '2019-08-07', 'dispFirstSubmitQcDate': '2022-08-02', 'resultsFirstSubmitDate': '2022-06-30', 'studyFirstSubmitQcDate': '2019-08-07', 'dispFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-02', 'studyFirstPostDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With a Reduction in Urine Protein Creatinine Ratio (UPC) of > 500 mg/Day From That Measured Before Enrollment', 'timeFrame': 'Baseline, Month 1'}, {'measure': 'Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment', 'timeFrame': 'Baseline, Month 2'}, {'measure': 'Number of Participants With a Reduction in UPC of > 500 mg/Day From That Measured Before Enrollment', 'timeFrame': 'Baseline, Month 3'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment', 'timeFrame': 'Baseline, Month 1'}, {'measure': 'Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment', 'timeFrame': 'Baseline, Month 2'}, {'measure': 'Number of Participants With Improvement in Estimated Glomerular Filtration Rate (eGFR) ≥25% From Before Enrollment', 'timeFrame': 'Baseline, Month 3'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 1'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 2'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 3'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 4'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 5'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 6'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 7'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 8'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 9'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 10'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 11'}, {'measure': 'Number of Participants With Reduction in Systolic Blood Pressure (SBP) of ≥ 10 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 5 mm Hg From Before Enrollment', 'timeFrame': 'Baseline, Week 12'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney Injury', 'Proteinuria', 'Hypertension', 'Anti-VEGF'], 'conditions': ['Kidney Injury', 'Proteinuria', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the hypothesis that isosorbide mononitrate prevents deterioration of renal function in patients receiving anti-angiogenic therapies that target vascular endothelial growth factor (VEGF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients on or enrolled for anti-VEGF therapy\n* new-onset proteinuria, defined as a urine protein: creatinine ratio (UPC) of \\>500mg/g or hypertension (Systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg) or a decrease in eGFR by ≥ 25% from baseline before starting therapy.\n\nExclusion Criteria:\n\n* Pregnant women\n* Breast-feeding women.'}, 'identificationModule': {'nctId': 'NCT04051957', 'briefTitle': 'Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0429'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Isosorbide Mononitrate', 'interventionNames': ['Drug: Isosorbide Mononitrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo oral tablet']}], 'interventions': [{'name': 'Isosorbide Mononitrate', 'type': 'DRUG', 'description': 'The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).', 'armGroupLabels': ['Isosorbide Mononitrate']}, {'name': 'Placebo oral tablet', 'type': 'DRUG', 'description': 'Placebo will be given daily and will be doubled after 4 weeks of start of therapy.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University Of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Jaya Kala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Kidney Foundation, United States', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jaya Kala', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}