Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-12 @ 11:25 PM
Study NCT ID:
NCT01755858
Status:
TERMINATED
Last Update Posted:
2020-08-11
First Post:
2012-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012078', 'term': 'Renal Artery Obstruction'}, {'id': 'D006978', 'term': 'Hypertension, Renovascular'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'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': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006977', 'term': 'Hypertension, Renal'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C506540', 'term': "arginyl-2,'6'-dimethyltyrosyl-lysyl-phenylalaninamide"}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jim.carr@stealthbt.com', 'phone': '1-617-600-6888', 'title': 'Jim Carr, Pharm.D. Chief Clinical Development Officer', 'organization': 'Stealth BioTherapeutics, Inc'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 2, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 5, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Labile Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood sodium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood magnesium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Blood potassium decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pedal pulse decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Thyroid function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Procedural Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Hyperphosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Nasal Dryness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}, {'term': 'Respiratory Distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'seriousEvents': [{'term': 'Vascular Pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (18.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.3', 'spread': '12.14', 'groupId': 'OG000'}, {'value': '12.0', 'spread': '23.84', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom GFR by iothalamate clearance was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'Right Single Kidney', 'categories': [{'measurements': [{'value': '0.238', 'spread': '0.2557', 'groupId': 'OG000'}, {'value': '0.010', 'spread': '0.0552', 'groupId': 'OG001'}]}]}, {'title': 'Left Single Kidney', 'categories': [{'measurements': [{'value': '0.012', 'spread': '0.1487', 'groupId': 'OG000'}, {'value': '0.120', 'spread': '0.1600', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean glomerular flow rate as measured using Multi-Detector Computed Tomography (MDCT) at baseline (pre-PTRA) and 8 weeks post-PTRA, stented quantifiable scanned kidneys.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with stented quantifiable kidneys for whom GFR by MDCT was measured at Baseline (pre-PTRA) and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'Right Cortical', 'categories': [{'measurements': [{'value': '1.266', 'spread': '0.9341', 'groupId': 'OG000'}, {'value': '-0.816', 'spread': '0.6614', 'groupId': 'OG001'}]}]}, {'title': 'Right Medullary', 'categories': [{'measurements': [{'value': '0.242', 'spread': '0.4143', 'groupId': 'OG000'}, {'value': '-0.082', 'spread': '0.2541', 'groupId': 'OG001'}]}]}, {'title': 'Left Cortical', 'categories': [{'measurements': [{'value': '0.614', 'spread': '1.2390', 'groupId': 'OG000'}, {'value': '0.220', 'spread': '0.9112', 'groupId': 'OG001'}]}]}, {'title': 'Left Medullary', 'categories': [{'measurements': [{'value': '0.150', 'spread': '0.3788', 'groupId': 'OG000'}, {'value': '0.156', 'spread': '0.5184', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean regional perfusion as measured by Multi-Detector Computed Tomography (MDCT) Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys.', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom regional perfusion was measured by MDCT with stented quantifiable scanned kidneys at Baseline (pre-PTRA) and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'Right Cortical', 'categories': [{'measurements': [{'value': '85.056', 'spread': '63.2943', 'groupId': 'OG000'}, {'value': '-28.406', 'spread': '54.8919', 'groupId': 'OG001'}]}]}, {'title': 'Right Medullary', 'categories': [{'measurements': [{'value': '6.658', 'spread': '20.3007', 'groupId': 'OG000'}, {'value': '-10.204', 'spread': '21.2044', 'groupId': 'OG001'}]}]}, {'title': 'Right Total', 'categories': [{'measurements': [{'value': '91.712', 'spread': '82.4794', 'groupId': 'OG000'}, {'value': '-38.608', 'spread': '43.4011', 'groupId': 'OG001'}]}]}, {'title': 'Left Cortical', 'categories': [{'measurements': [{'value': '23.928', 'spread': '64.4891', 'groupId': 'OG000'}, {'value': '35.090', 'spread': '59.9470', 'groupId': 'OG001'}]}]}, {'title': 'Left Medullary', 'categories': [{'measurements': [{'value': '3.610', 'spread': '14.4951', 'groupId': 'OG000'}, {'value': '5.930', 'spread': '19.0256', 'groupId': 'OG001'}]}]}, {'title': 'Left Total', 'categories': [{'measurements': [{'value': '27.538', 'spread': '78.0728', 'groupId': 'OG000'}, {'value': '41.018', 'spread': '75.6824', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean renal blood flow (ml/minute) as measured using Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys', 'unitOfMeasure': 'mL/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom renal blood flow as measured by MDCT was measured in stented quantifiable scanned kidneys at baseline and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'Right Total Kidney Volume', 'categories': [{'measurements': [{'value': '1.270', 'spread': '12.8218', 'groupId': 'OG000'}, {'value': '4.708', 'spread': '13.7198', 'groupId': 'OG001'}]}]}, {'title': 'Left Total Kidney Volume', 'categories': [{'measurements': [{'value': '5.090', 'spread': '17.6951', 'groupId': 'OG000'}, {'value': '10.220', 'spread': '8.9447', 'groupId': 'OG001'}]}]}, {'title': 'Right Cortical', 'categories': [{'measurements': [{'value': '4.372', 'spread': '10.5438', 'groupId': 'OG000'}, {'value': '9.840', 'spread': '13.1156', 'groupId': 'OG001'}]}]}, {'title': 'Right Medullary', 'categories': [{'measurements': [{'value': '-3.162', 'spread': '4.7616', 'groupId': 'OG000'}, {'value': '-5.132', 'spread': '7.0670', 'groupId': 'OG001'}]}]}, {'title': 'Left Cortical', 'categories': [{'measurements': [{'value': '4.534', 'spread': '15.0459', 'groupId': 'OG000'}, {'value': '10.100', 'spread': '10.8462', 'groupId': 'OG001'}]}]}, {'title': 'Left Medullary', 'categories': [{'measurements': [{'value': '0.558', 'spread': '3.1016', 'groupId': 'OG000'}, {'value': '0.120', 'spread': '8.6277', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRA', 'description': 'Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom renal volume was measured at baseline (Pre-PTRA) and 8 weeks post-PTRA in stented quantifiable kidneys.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'AxialRightPrefurosemideFractHyp%>20 27H Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.440', 'spread': '34.6825', 'groupId': 'OG000'}, {'value': '16.708', 'spread': '19.4980', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPrefurosemideFractHyp%>20; 8Wk Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.380', 'spread': '8.5013', 'groupId': 'OG000'}, {'value': '-10.892', 'spread': '15.370', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPrefurosemideFractHyp%>30 27H PostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.206', 'spread': '9.4875', 'groupId': 'OG000'}, {'value': '11.600', 'spread': '17.8192', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPrefurosemideFractHyp%>30 8Wk PostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.120', 'spread': '2.7426', 'groupId': 'OG000'}, {'value': '-1.840', 'spread': '2.8693', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPostfurosemideFracHyp%>20 27HPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.280', 'spread': '27.6206', 'groupId': 'OG000'}, {'value': '13.854', 'spread': '26.2292', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPostfurosemideFracHyp%>20 8WkPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.625', 'spread': '8.9537', 'groupId': 'OG000'}, {'value': '-7.560', 'spread': '13.5471', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPostfurosemideFracHyp %30 27H Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.080', 'spread': '7.6904', 'groupId': 'OG000'}, {'value': '13.490', 'spread': '21.1322', 'groupId': 'OG001'}]}]}, {'title': 'AxialRightPostfurosemideFracHyp%>30 8WkPost PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.400', 'spread': '2.9473', 'groupId': 'OG000'}, {'value': '-1.370', 'spread': '3.4412', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeftPrefurosemide Frac Hyp%>20 27H Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.320', 'spread': '21.7694', 'groupId': 'OG000'}, {'value': '12.767', 'spread': '26.0745', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeftPrefurosemide Frac Hyp%>20 8Wk Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.420', 'spread': '17.3066', 'groupId': 'OG000'}, {'value': '-8.160', 'spread': '16.4477', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft Prefurosemide Frac Hyp %>30 27H PostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.128', 'spread': '3.0154', 'groupId': 'OG000'}, {'value': '16.938', 'spread': '25.4089', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft PrefurosemideFrac Hyp %>30 8Wk PostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.602', 'spread': '7.1510', 'groupId': 'OG000'}, {'value': '-6.360', 'spread': '11.3054', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft Post-FurosemideFrac Hyp%>20 27HPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.148', 'spread': '21.0184', 'groupId': 'OG000'}, {'value': '14.083', 'spread': '34.6825', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft Post-FurosemideFrac Hyp%>20 8WkPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.012', 'spread': '17.3829', 'groupId': 'OG000'}, {'value': '-14.220', 'spread': '13.303', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft Post-FurosemideFrac Hyp%>30 27HPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.874', 'spread': '2.5111', 'groupId': 'OG000'}, {'value': '18.757', 'spread': '27.1441', 'groupId': 'OG001'}]}]}, {'title': 'AxialLeft Post-FurosemideFrac Hyp%>30 8WkPostPTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.858', 'spread': '7.0087', 'groupId': 'OG000'}, {'value': '-5.704', 'spread': '8.3550', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Pre-PTRA) , 27 hours post-PTRA and 8 weeks post-PTRA', 'description': 'Mean change in renal oxygenation, axial aspect, in stented kidneys between baseline (pre-PTRA), and 27 hours post-PTRA and 8 weeks post-PTRA as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging.', 'unitOfMeasure': 's^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom fractional renal oxygenation, axial aspect, in stented kidneys was measured at baseline, 27 hours post-PTRA and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': 'CoronalRtFractHypoxia% >20Prefuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.314', 'spread': '33.3525', 'groupId': 'OG000'}, {'value': '9.083', 'spread': '17.3368', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >20Prefuros.8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.140', 'spread': '16.4690', 'groupId': 'OG000'}, {'value': '-2.220', 'spread': '7.5549', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >30Prefuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.800', 'spread': '9.6734', 'groupId': 'OG000'}, {'value': '9.250', 'spread': '30.6001', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >30Prefuros8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.300', 'spread': '10.1403', 'groupId': 'OG000'}, {'value': '-2.852', 'spread': '11.1986', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >20Postfuros27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.800', 'spread': '33.5328', 'groupId': 'OG000'}, {'value': '3.840', 'spread': '22.4825', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >20Postfuros8WKPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.233', 'spread': '7.5142', 'groupId': 'OG000'}, {'value': '-5.220', 'spread': '4.6018', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >30Postfuros27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.875', 'spread': '13.2666', 'groupId': 'OG000'}, {'value': '11.458', 'spread': '32.8826', 'groupId': 'OG001'}]}]}, {'title': 'CoronalRtFractHypoxia% >30Postfuros8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.233', 'spread': '3.5119', 'groupId': 'OG000'}, {'value': '-8.158', 'spread': '16.5393', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >20Prefuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.000', 'spread': '23.7674', 'groupId': 'OG000'}, {'value': '6.033', 'spread': '31.1820', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >20Prefuros.8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.125', 'spread': '10.2970', 'groupId': 'OG000'}, {'value': '-0.525', 'spread': '12.5077', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >30Prefuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.000', 'spread': '8.9272', 'groupId': 'OG000'}, {'value': '22.615', 'spread': '35.6971', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >30Prefuros.8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.275', 'spread': '4.4650', 'groupId': 'OG000'}, {'value': '-1.525', 'spread': '12.3605', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >20Postfuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.240', 'spread': '24.5671', 'groupId': 'OG000'}, {'value': '6.783', 'spread': '29.1337', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >20Postfuros.8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.375', 'spread': '9.2525', 'groupId': 'OG000'}, {'value': '-0.700', 'spread': '14.7384', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >30Postfuros.27HPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.080', 'spread': '7.3145', 'groupId': 'OG000'}, {'value': '20.345', 'spread': '31.5024', 'groupId': 'OG001'}]}]}, {'title': 'CoronalLeftFractHypoxia% >30Postfuros.8WkPost-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.250', 'spread': '2.0873', 'groupId': 'OG000'}, {'value': '-4.225', 'spread': '12.7899', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '27H post PTRA and 8 weeks Post PTRA', 'description': 'Mean change in renal oxygenation, coronal aspect, in stented kidneys between baseline (pre-PTRA) and 27 hours post-PTRA or 8 weeks post-PTRA, as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging, with and without Bendavia', 'unitOfMeasure': 's^-1', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom fractional renal oxygenation, coronal aspect, in stented kidneys was measured at baseline, 27 hours post-PTRA and 8 weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.\n\nBendavia'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.\n\nPlacebo'}], 'classes': [{'title': '27 Hours Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '14.78', 'groupId': 'OG000'}, {'value': '-3.8', 'spread': '15.69', 'groupId': 'OG001'}]}]}, {'title': '8 weeks Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '19.88', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '30.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRA', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom systolic blood pressure was measured at baseline (pre-PTRA) and 27 hours post-PTRA, or 8(+4) weeks post-PTRA.'}, {'type': 'SECONDARY', 'title': 'Mean Change in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'classes': [{'title': '27 Hours Post-PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '7.76', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '9.88', 'groupId': 'OG001'}]}]}, {'title': '8 Weeks Post PTRA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.70', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '9.80', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRA', 'description': 'Mean Change in Diastolic Blood Pressure (DBP) values (mmHg) from baseline (pre-PTRA), immediately post-PTRA, 27 hours and 8 weeks post-PTRA, with and without Bendavia.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants for whom diastolic blood pressure was measured.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.1', 'spread': '6.41', 'groupId': 'BG000'}, {'value': '72.6', 'spread': '7.78', 'groupId': 'BG001'}, {'value': '69.8', 'spread': '7.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus Status', 'classes': [{'categories': [{'title': 'Positive', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Negative', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-10', 'studyFirstSubmitDate': '2012-12-19', 'resultsFirstSubmitDate': '2020-07-24', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-10', 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Mean Glomerular Filtration Rate (GFR), as Measured by Iothalamate Clearance, at Baseline (Pre-percutaneous Renal Artery Angioplasty and 8 Weeks Post-PTRA.', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean glomerular filtration rate (GFR), as measured by iothalamate clearance, from baseline (pre-percutaneous renal artery angioplasty, or pre-PTRA) and 8 weeks post-PTRA..'}], 'secondaryOutcomes': [{'measure': 'Change in Mean Glomerular Flow Rate as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean glomerular flow rate as measured using Multi-Detector Computed Tomography (MDCT) at baseline (pre-PTRA) and 8 weeks post-PTRA, stented quantifiable scanned kidneys.'}, {'measure': 'Change in Mean Regional Perfusion as Measured by MDCT at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean regional perfusion as measured by Multi-Detector Computed Tomography (MDCT) Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys.'}, {'measure': 'Change in Mean Renal Blood Flow as Measured Using Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA', 'timeFrame': 'Baseline (pre-PTRA) and 8 weeks post-PTRA', 'description': 'Change in mean renal blood flow (ml/minute) as measured using Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA for stented quantifiable scanned kidneys'}, {'measure': 'Change in Mean Renal Volume as Measured by Multi-Detector Computed Tomography (MDCT) at Baseline (Pre-PTRA) and 8 Weeks Post-PTRA.', 'timeFrame': 'Baseline (Pre-PTRA) and 8 (+4) weeks post-PTRA', 'description': 'Change in mean renal volume as measured by Multi-Detector Computed Tomography (MDCT) at Baseline (pre-PTRA) and 8 weeks post-PTRA.'}, {'measure': 'Mean Change in Renal Oxygenation, Axial Aspect, in Stented Kidneys From Baseline (Pre-PTRA), and 27 Hours Post-PTRA and 8 Weeks Post-PTRA', 'timeFrame': 'Baseline (Pre-PTRA) , 27 hours post-PTRA and 8 weeks post-PTRA', 'description': 'Mean change in renal oxygenation, axial aspect, in stented kidneys between baseline (pre-PTRA), and 27 hours post-PTRA and 8 weeks post-PTRA as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging.'}, {'measure': 'Mean Change in Renal Oxygenation, Coronal Aspect, in Stented Kidneys Between Baseline Pre-PTRA, 27 Hours Post-PTRA and 8 Weeks Post-PTRA', 'timeFrame': '27H post PTRA and 8 weeks Post PTRA', 'description': 'Mean change in renal oxygenation, coronal aspect, in stented kidneys between baseline (pre-PTRA) and 27 hours post-PTRA or 8 weeks post-PTRA, as measured by calculation of fractional hypoxia using blood oxygenation level-dependent magnetic resonance (BOLD-MR) imaging, with and without Bendavia'}, {'measure': 'Mean Change in Systolic Blood Pressure Values (mmHg) From Pre-PTRA, Immediately Post-PTRA, 27 Hours and 8 (+4) Weeks Post-PTRA', 'timeFrame': 'Pre-PTRA and 27 hours post-PTRA and 8 weeks post-PTRA'}, {'measure': 'Mean Change in Diastolic Blood Pressure', 'timeFrame': 'Pre-PTRA, immediately post-PTRA, 27 hours post-PTRA and 8 weeks post-PTRA', 'description': 'Mean Change in Diastolic Blood Pressure (DBP) values (mmHg) from baseline (pre-PTRA), immediately post-PTRA, 27 hours and 8 weeks post-PTRA, with and without Bendavia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['elamipretide'], 'conditions': ['Renal Artery Obstruction', 'Hypertension, Renovascular', 'Ischemia Reperfusion Injury']}, 'referencesModule': {'references': [{'pmid': '28916603', 'type': 'DERIVED', 'citation': 'Saad A, Herrmann SMS, Eirin A, Ferguson CM, Glockner JF, Bjarnason H, McKusick MA, Misra S, Lerman LO, Textor SC. Phase 2a Clinical Trial of Mitochondrial Protection (Elamipretide) During Stent Revascularization in Patients With Atherosclerotic Renal Artery Stenosis. Circ Cardiovasc Interv. 2017 Sep;10(9):e005487. doi: 10.1161/CIRCINTERVENTIONS.117.005487.'}]}, 'descriptionModule': {'briefSummary': 'This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with Atherosclerotic Renal Artery Stenosis (ARAS), who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).', 'detailedDescription': 'This was a Phase 2a prospective, single center, randomized, double-blind, placebo-controlled study designed to assess the efficacy, pharmacokinetics, safety and tolerability of IV elamipretide for reduction of reperfusion injury in subjects with ARAS, who are undergoing percutaneous transluminal angioplasty of the renal artery (PTRA).\n\nThe randomization (1:1 active:placebo) was stratified by a diagnosis of diabetes mellitus. Participants received either 0.05 mg/kg/h elamipretide or matching placebo, administered as an IV infusion at 60 mL/h infused 30 minutes before and continued 3 hours after PTRA of the renal artery. After completion of the PTRA and stenting, subjects were to receive standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥40 and ≤80 years old.\n* Patients with hypertension (systolic blood pressure \\[BP\\] \\>155 mm Hg) and/or requiring 2 or more antihypertensive medications: no restrictions will be placed on antihypertensive agents, although loop diuretics will be temporarily changed to diluting site agents (eg, hydrochlorothiazide, indapamide, metolazone) prior to each blood oxygen level-dependent magnetic resonance imaging (BOLD-MRI) study performed during the trial, unless, in the judgment of the Investigator, the change represents a hazard to the patient. ARAS patients will be identified based upon radiologic and clinical criteria suggestive of renovascular hypertension and/or hemodynamically significant renovascular disease \\>60% lumen occlusion (determined by quantitative computed tomography angiography or Doppler ultrasound velocity \\>200 cm/sec).\n* Have an estimated glomerular filtration rate of ≥15 ml/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.\n* Have no contraindications to angiography such as severe contrast allergy.\n* Have no contraindications to non-contrast magnetic resonance evaluations such as a pacemaker or magnetically active metal fragments.\n* Able to comply with protocol.\n* Women of childbearing age must:\n* Have a negative pregnancy serum human chorionic gonadotropin test prior to receiving study drug.\n* Agree to use two forms of contraception for 3 months following receipt of the study drug.\n* Men who are sexually active and able to father a child, must agree to use one of the birth control methods listed below for the entire study and for at least 2 months after receiving the study drug:\n* Barrier methods (such as a condom or diaphragm) used with a spermicide.\n* Hormonal methods used by his partner, such as birth control pills, patches, injections, vaginal ring, or implants.\n* Intrauterine device (IUD) used by his partner.\n* Abstinence (no sex).\n* Competent and able to provide written informed consent\n\nExclusion Criteria:\n\n* Advanced chronic kidney disease defined as either Stage 5 or end-stage renal disease requiring dialysis.\n* Have other clinically significant abnormalities or laboratory results that would, in the opinion of the investigators, compromise the safety of the patient including evidence of diabetic ketoacidosis, paraproteinemia, or triglycerides above 600 mg/dL.\n* Clinically significant medical conditions within the six months before administration of Bendavia (e.g., cancer, stroke, myocardial infarction, active angina, congestive heart failure) that would, in the opinion of the investigators, compromise the safety of the patient.\n* Have received an investigational drug within thirty (30) days of baseline.\n* Have a serum sodium \\<135 mmol/L on the day of, and prior to, the PTRA.\n* Are pregnant or breast feeding.'}, 'identificationModule': {'nctId': 'NCT01755858', 'acronym': 'EVOLVE', 'briefTitle': 'Effects of Intravenous Bendavia™ on Reperfusion Injury in Patients Undergoing Angioplasty of the Renal Artery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stealth BioTherapeutics Inc.'}, 'officialTitle': 'A Phase 2a, Placebo-controlled Trial to Evaluate the Impact of Intravenous Bendavia™ on Ischemia Reperfusion Injury in Atherosclerotic Renal Artery Stenosis in Patients Undergoing Percutaneous Transluminal Angioplasty of the Renal Artery', 'orgStudyIdInfo': {'id': 'SPIRI-225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bendavia', 'description': 'Bendavia, intravenous infusion, 0.05 mg/kg/hr for a maximum duration of 4 hours.', 'interventionNames': ['Drug: Bendavia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (no active drug), intravenous infusion, for a maximum duration of 4 hours.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bendavia', 'type': 'DRUG', 'otherNames': ['MTP-131', 'Elamipretide'], 'armGroupLabels': ['Bendavia']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Stephen C Textor, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}, {'name': 'Richard Straube, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stealth BioTherapeutics Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stealth BioTherapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}