Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-01 @ 7:55 AM
Study NCT ID:
NCT02742103
Status:
COMPLETED
Last Update Posted:
2020-06-11
First Post:
2016-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '6108784000', 'title': 'Trial Registration Coordinator', 'organization': 'CSL Behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '67 days for each subject', 'eventGroups': [{'id': 'EG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 18, 'seriousNumAtRisk': 52, 'deathsNumAffected': 2, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 12, 'seriousNumAtRisk': 28, 'deathsNumAffected': 2, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'seriousEvents': [{'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post concussion syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Post procedural haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Microcytic anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Haemoptysis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Ataxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Vestibular disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal erosion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Nephropathy toxic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 52, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference (CSL112 - placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.124', 'ciLowerLimit': '-0.296', 'ciUpperLimit': '-0.005', 'statisticalMethod': 'Newcombe-Wilson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'A renal SAE is defined as any SAE with a MedDRA preferred term included in the Acute Renal Failure narrow Standard MedDRA Query or a preferred term of renal tubular necrosis, renal cortical necrosis, renal necrosis, or renal papillary necrosis.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety (SAF) Population consisted of all subjects who received at least a partial dose of investigational product.'}, {'type': 'PRIMARY', 'title': 'Percent of Participants With Treatment-emergent Acute Kidney Injury (AKI )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Rate difference (CSL112 - placebo)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.103', 'ciLowerLimit': '-0.277', 'ciUpperLimit': '0.025', 'statisticalMethod': 'Newcombe-Wilson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Acute kidney injury is defined as an absolute increase in serum creatinine from baseline ≥ 0.3 mg/dL during the Active Treatment Period that is sustained upon repeat measurement by the central laboratory no earlier than 24 hours after the elevated value. If no repeat value is obtained, a single serum creatinine value that is increased from baseline ≥ 0.3 mg/dL (26.5 μmol/L) during the Active Treatment Period would also fulfil the definition of AKI.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '73.1', 'groupId': 'OG000'}, {'value': '71.4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Total Number of TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'unitOfMeasure': 'Number of TEAEs', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': "Adverse drug reactions or suspected adverse drug reactions are defined as:\n\n1. All TEAEs, including local tolerability events, that begin during or within 1 hour after the end of an infusion; or\n2. Those TEAEs that the investigator or sponsor indicate may be causally related to product administration; or\n3. All TEAEs for which the Investigator's causality assessment is missing or indeterminate; or\n4. All TEAEs for which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': "Adverse drug reactions or suspected adverse drug reactions are defined as:\n\n1. All TEAEs, including local tolerability events, that begin during or within 1 hour after the end of an infusion; or\n2. Those TEAEs that the investigator or sponsor indicate may be causally related to product administration; or\n3. All TEAEs for which the Investigator's causality assessment is missing or indeterminate; or\n4. All TEAEs for which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Renal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': '≤ baseline value', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '> 0 to < 0.3 mg/dL', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': '≥ 0.3 to ≤ 0.5 mg/dL', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': '> 0.5 mg/dL', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': '≥ 1.5 × Baseline', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 2 × Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 3 × Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 4.0 mg/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in eGFR by ≥ 25%', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Initiation of renal replacement therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Number of participants with changes in renal status defined as:\n\n* Absolute increases from baseline in serum creatinine as follows:\n\n i. ≤ baseline value ii. \\> 0 to \\< 0.3 mg/dL iii. ≥ 0.3 to ≤ 0.5 mg/dL iv. \\> 0.5 mg/dL\n* Increases in serum creatinine that are sustained for ≥ 24 hours upon repeat measurement that are greater than or equal to 1.5 x, 2 x, or 3.0 x the baseline value, or serum creatinine ≥ 4.0 mg/dL\n* Initiation of renal replacement therapy\n* Decrease in eGFR ≥ 25% from baseline starting during the active treatment period and that is sustained at the final study visit', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Renal Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': '≤ Baseline Value', 'categories': [{'measurements': [{'value': '17.3', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}, {'title': '> 0 to < 0.3 mg/dL', 'categories': [{'measurements': [{'value': '67.3', 'groupId': 'OG000'}, {'value': '64.3', 'groupId': 'OG001'}]}]}, {'title': '≥ 0.3 to ≤ 0.5 mg/dL', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': '> 0.5 mg/dL', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': '≥ 1.5 × Baseline', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 2 × Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 3 × Baseline', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': '≥ 4.0 mg/dL', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Decrease in eGFR by ≥ 25%', 'categories': [{'measurements': [{'value': '9.6', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'Initiation of renal replacement therapy', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Percentage of participants with changes in renal status defined as:\n\n* Absolute increases from baseline in serum creatinine as follows:\n\n i. ≤ baseline value ii. \\> 0 to \\< 0.3 mg/dL iii. ≥ 0.3 to ≤ 0.5 mg/dL iv. \\> 0.5 mg/dL\n* Increases in serum creatinine that are sustained for ≥ 24 hours upon repeat measurement that are greater than or equal to 1.5 x, 2 x, or 3.0 x the baseline value, or serum creatinine ≥ 4.0 mg/dL\n* Initiation of renal replacement therapy\n* Decrease in eGFR ≥ 25% from baseline starting during the active treatment period and that is sustained at the final study visit', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change in Hepatic Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': 'total bilirubin > 1.5 x ULN', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'total bilirubin > 2 x ULN', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 3 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 5 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 10 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "Possible Hy's law cases", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': "Number of participants with a change from baseline in hepatic status and that is sustained for ≥ 24 hours upon repeat measurement, defined as:\n\n1. Alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN)\n2. ALT \\> 5 x ULN\n3. ALT \\> 10 x ULN\n4. Serum total bilirubin \\> 1.5 x ULN\n5. Serum total bilirubin \\> 2 x ULN\n6. Possible Hy's law cases, as defined in the FDA Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Change in Hepatic Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': 'total bilirubin > 1.5 x ULN', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'total bilirubin > 2 x ULN', 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 3 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 5 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'ALT > 10 x ULN', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': "Possible Hy's law cases", 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 4 weeks', 'description': "Percentage of participants with a change from baseline in hepatic status and that is sustained for ≥ 24 hours upon repeat measurement, defined as:\n\n1. Alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN)\n2. ALT \\> 5 x ULN\n3. ALT \\> 10 x ULN\n4. Serum total bilirubin \\> 1.5 x ULN\n5. Serum total bilirubin \\> 2 x ULN\n6. Possible Hy's law cases, as defined in the FDA Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009).", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-emergent Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'Bleeding events are as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al., 2011).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'groupId': 'OG000'}, {'value': '17.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'description': 'Bleeding events are as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al., 2011).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Binding Antibodies Specific to Apolipoprotein A-I (Apo-A1) and CSL112', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': 'CSL112 antibody', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'apoA-I antibody', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 9 weeks', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SAF'}, {'type': 'SECONDARY', 'title': 'Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 1 for apoA-I and PC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': 'apoA-I', 'categories': [{'measurements': [{'value': '124.6', 'spread': '25.38', 'groupId': 'OG000'}, {'value': '-4.5', 'spread': '9.46', 'groupId': 'OG001'}]}]}, {'title': 'PC', 'categories': [{'measurements': [{'value': '198.4', 'spread': '43.56', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '15.04', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after end of infusion', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'SECONDARY', 'title': 'Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 4 for apoA-I and PC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'classes': [{'title': 'apoA-I', 'categories': [{'measurements': [{'value': '141.5', 'spread': '41.11', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '23.57', 'groupId': 'OG001'}]}]}, {'title': 'PC', 'categories': [{'measurements': [{'value': '200.0', 'spread': '71.78', 'groupId': 'OG000'}, {'value': '-13.2', 'spread': '27.96', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after end of infusion', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK'}, {'type': 'SECONDARY', 'title': 'Plasma apoA-I and Phosphatidylcholine (PC) Accumulation Ratio After Infusion 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}], 'classes': [{'title': 'apoA-I', 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.32', 'groupId': 'OG000'}]}]}, {'title': 'PC', 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Immediately after end of infusion', 'description': 'The plasma apoA-I and PC accumulation ratio will be determined for CSL112-treated subjects.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic Population (PK) consists of all subjects in the SAF who had at least 1 measurable plasma concentration of either apoA-I or PC.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Moved to another town', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'preAssignmentDetails': 'To ensure that at least 1/3 of the study population had an estimated glomerular filtration (eGFR) in the chronic kidney disease (CKD) Stage 3b range, no more than 2/3 of the study population were to have an eGFR in the CKD Stage 3a range. Randomization was stratified by eGFR and by medical history of diabetes.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).\n\nCSL\\_112: CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.\n\nPlacebo: 0.9% weight/volume sodium chloride solution (ie, normal saline)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.6', 'spread': '10.95', 'groupId': 'BG000'}, {'value': '71.9', 'spread': '10.12', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '10.63', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18-64 years', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}, {'title': '65-84 years', 'categories': [{'measurements': [{'value': '42', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}]}, {'title': '85 years and over', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-06-06', 'size': 2161916, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-26T09:00', 'hasProtocol': True}, {'date': '2017-08-03', 'size': 1631313, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-05-26T09:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'dispFirstSubmitDate': '2018-06-19', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2016-03-30', 'dispFirstSubmitQcDate': '2018-06-19', 'resultsFirstSubmitDate': '2020-05-26', 'studyFirstSubmitQcDate': '2016-04-13', 'dispFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-26', 'studyFirstPostDateStruct': {'date': '2016-04-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of Participants With at Least One Occurrence of Treatment-emergent Renal Serious Adverse Events (SAEs) (SAF)', 'timeFrame': 'Up to 9 weeks', 'description': 'A renal SAE is defined as any SAE with a MedDRA preferred term included in the Acute Renal Failure narrow Standard MedDRA Query or a preferred term of renal tubular necrosis, renal cortical necrosis, renal necrosis, or renal papillary necrosis.'}, {'measure': 'Percent of Participants With Treatment-emergent Acute Kidney Injury (AKI )', 'timeFrame': 'Up to 4 weeks', 'description': 'Acute kidney injury is defined as an absolute increase in serum creatinine from baseline ≥ 0.3 mg/dL during the Active Treatment Period that is sustained upon repeat measurement by the central laboratory no earlier than 24 hours after the elevated value. If no repeat value is obtained, a single serum creatinine value that is increased from baseline ≥ 0.3 mg/dL (26.5 μmol/L) during the Active Treatment Period would also fulfil the definition of AKI.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 9 weeks'}, {'measure': 'Percentage of Participants With TEAEs', 'timeFrame': 'Up to 9 weeks'}, {'measure': 'Total Number of TEAEs', 'timeFrame': 'Up to 9 weeks'}, {'measure': 'Number of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR', 'timeFrame': 'Up to 9 weeks', 'description': "Adverse drug reactions or suspected adverse drug reactions are defined as:\n\n1. All TEAEs, including local tolerability events, that begin during or within 1 hour after the end of an infusion; or\n2. Those TEAEs that the investigator or sponsor indicate may be causally related to product administration; or\n3. All TEAEs for which the Investigator's causality assessment is missing or indeterminate; or\n4. All TEAEs for which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more."}, {'measure': 'Percentage of Participants With Treatment-emergent Adverse Drug Reaction (ADR) or Suspected ADR', 'timeFrame': 'Up to 9 weeks', 'description': "Adverse drug reactions or suspected adverse drug reactions are defined as:\n\n1. All TEAEs, including local tolerability events, that begin during or within 1 hour after the end of an infusion; or\n2. Those TEAEs that the investigator or sponsor indicate may be causally related to product administration; or\n3. All TEAEs for which the Investigator's causality assessment is missing or indeterminate; or\n4. All TEAEs for which the incidence in an active treatment arm exceeds the exposure-adjusted incidence rate in the placebo arm by 30% or more, provided the difference in incidence rates is 1% or more."}, {'measure': 'Number of Participants With Change in Renal Status', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Number of participants with changes in renal status defined as:\n\n* Absolute increases from baseline in serum creatinine as follows:\n\n i. ≤ baseline value ii. \\> 0 to \\< 0.3 mg/dL iii. ≥ 0.3 to ≤ 0.5 mg/dL iv. \\> 0.5 mg/dL\n* Increases in serum creatinine that are sustained for ≥ 24 hours upon repeat measurement that are greater than or equal to 1.5 x, 2 x, or 3.0 x the baseline value, or serum creatinine ≥ 4.0 mg/dL\n* Initiation of renal replacement therapy\n* Decrease in eGFR ≥ 25% from baseline starting during the active treatment period and that is sustained at the final study visit'}, {'measure': 'Percentage of Participants With Change in Renal Status', 'timeFrame': 'Baseline and up to 4 weeks', 'description': 'Percentage of participants with changes in renal status defined as:\n\n* Absolute increases from baseline in serum creatinine as follows:\n\n i. ≤ baseline value ii. \\> 0 to \\< 0.3 mg/dL iii. ≥ 0.3 to ≤ 0.5 mg/dL iv. \\> 0.5 mg/dL\n* Increases in serum creatinine that are sustained for ≥ 24 hours upon repeat measurement that are greater than or equal to 1.5 x, 2 x, or 3.0 x the baseline value, or serum creatinine ≥ 4.0 mg/dL\n* Initiation of renal replacement therapy\n* Decrease in eGFR ≥ 25% from baseline starting during the active treatment period and that is sustained at the final study visit'}, {'measure': 'Number of Participants With Change in Hepatic Status', 'timeFrame': 'Baseline and up to 4 weeks', 'description': "Number of participants with a change from baseline in hepatic status and that is sustained for ≥ 24 hours upon repeat measurement, defined as:\n\n1. Alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN)\n2. ALT \\> 5 x ULN\n3. ALT \\> 10 x ULN\n4. Serum total bilirubin \\> 1.5 x ULN\n5. Serum total bilirubin \\> 2 x ULN\n6. Possible Hy's law cases, as defined in the FDA Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009)."}, {'measure': 'Percentage of Participants With Change in Hepatic Status', 'timeFrame': 'Baseline and up to 4 weeks', 'description': "Percentage of participants with a change from baseline in hepatic status and that is sustained for ≥ 24 hours upon repeat measurement, defined as:\n\n1. Alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN)\n2. ALT \\> 5 x ULN\n3. ALT \\> 10 x ULN\n4. Serum total bilirubin \\> 1.5 x ULN\n5. Serum total bilirubin \\> 2 x ULN\n6. Possible Hy's law cases, as defined in the FDA Guidance for Industry: Drug-Induced Liver Injury: Premarketing Clinical Evaluation (July 2009)."}, {'measure': 'Number of Participants With Treatment-emergent Bleeding Events', 'timeFrame': 'Up to 9 weeks', 'description': 'Bleeding events are as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al., 2011).'}, {'measure': 'Percentage of Participants With Treatment-emergent Bleeding Events', 'timeFrame': 'Up to 9 weeks', 'description': 'Bleeding events are as defined by the Bleeding Academic Research Consortium (BARC) criteria (Mehran et al., 2011).'}, {'measure': 'Percentage of Participants With Binding Antibodies Specific to Apolipoprotein A-I (Apo-A1) and CSL112', 'timeFrame': 'Up to 9 weeks'}, {'measure': 'Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 1 for apoA-I and PC', 'timeFrame': 'Immediately after end of infusion'}, {'measure': 'Baseline-corrected Plasma Concentration Maximum (Cmax) After Infusion 4 for apoA-I and PC', 'timeFrame': 'Immediately after end of infusion'}, {'measure': 'Plasma apoA-I and Phosphatidylcholine (PC) Accumulation Ratio After Infusion 4', 'timeFrame': 'Immediately after end of infusion', 'description': 'The plasma apoA-I and PC accumulation ratio will be determined for CSL112-treated subjects.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acute Myocardial Infarction', 'Moderate Renal Impairment']}, 'referencesModule': {'references': [{'pmid': '33217027', 'type': 'DERIVED', 'citation': 'Zheng B, Duffy D, Tricoci P, Kastrissios H, Pfister M, Wright SD, Gille A, Tortorici MA. Pharmacometric analyses to characterize the effect of CSL112 on apolipoprotein A-I and cholesterol efflux capacity in acute myocardial infarction patients. Br J Clin Pharmacol. 2021 Jun;87(6):2558-2571. doi: 10.1111/bcp.14666. Epub 2020 Dec 23.'}, {'pmid': '30580130', 'type': 'DERIVED', 'citation': 'Gibson CM, Kerneis M, Yee MK, Daaboul Y, Korjian S, Mehr AP, Tricoci P, Alexander JH, Kastelein JJP, Mehran R, Bode C, Lewis BS, Mehta R, Duffy D, Feaster J, Halabi M, Angiolillo DJ, Duerschmied D, Ophuis TO, Merkely B. The CSL112-2001 trial: Safety and tolerability of multiple doses of CSL112 (apolipoprotein A-I [human]), an intravenous formulation of plasma-derived apolipoprotein A-I, among subjects with moderate renal impairment after acute myocardial infarction. Am Heart J. 2019 Feb;208:81-90. doi: 10.1016/j.ahj.2018.11.008. Epub 2018 Nov 22.'}]}, 'descriptionModule': {'briefSummary': 'This study is a phase 2, multicenter, double-blind, randomized, placebo controlled, parallel-group study to investigate the renal safety and tolerability of multiple dose intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate renal impairment (RI) and acute myocardial infarction (AMI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Men or women, at least 18 years of age, with evidence of moderate renal impairment (an eGFR ≥ 30 and \\<60 mL/min/1.73 m2) and myocardial necrosis in a clinical setting consistent with a type I (spontaneous) acute myocardial infarction (AMI).\n\nExclusion Criteria:\n\n* Symptoms, biomarker elevation or electrocardiogram (ECG) changes other than those of the index event that are consistent with a diagnosis of AMI but are likely not due to primary myocardial ischemia\n* Ongoing hemodynamic instability\n* Planned coronary artery bypass surgery\n* Evidence of hepatobiliary disease\n* History of acute kidney injury (AKI) after previous exposure to an intravenous contrast agent.\n* History of nephrotic range proteinuria.\n* Known history of allergy to soy beans or peanuts, immunoglobulin A (IgA) deficiency, antibodies to IgA , or hypersensitivity to CSL112 or any of its components.\n* Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study.'}, 'identificationModule': {'nctId': 'NCT02742103', 'briefTitle': 'A Study of CSL112 in Adults With Moderate Renal Impairment and Acute Myocardial Infarction', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Phase 2, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Moderate Renal Impairment and Acute Myocardial Infarction', 'orgStudyIdInfo': {'id': 'CSL112_2001'}, 'secondaryIdInfos': [{'id': '2015-003017-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL_112', 'description': 'CSL112 will be administered intravenously, once weekly for 4 consecutive weeks (4 infusions in total).', 'interventionNames': ['Biological: CSL_112']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'CSL_112', 'type': 'BIOLOGICAL', 'description': 'CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.', 'armGroupLabels': ['CSL_112']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '0.9% weight/volume sodium chloride solution (ie, normal saline)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site 16101', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'facility': 'Study Site 16078', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '94520', 'city': 'Concord', 'state': 'California', 'country': 'United States', 'facility': 'Study Site 16168', 'geoPoint': {'lat': 37.97798, 'lon': -122.03107}}, {'zip': '80120', 'city': 'Littleton', 'state': 'Colorado', 'country': 'United States', 'facility': 'Study Site 16130', 'geoPoint': {'lat': 39.61332, 'lon': -105.01665}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Study Site 16135', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '32209', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Study Site 16003', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '83712', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Study Site 16112', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '71301', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Study Site 16208', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '49770', 'city': 'Petoskey', 'state': 'Michigan', 'country': 'United States', 'facility': 'Study Site 16061', 'geoPoint': {'lat': 45.37334, 'lon': -84.95533}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site 16056', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27762', 'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Study Site 16014', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Study Site 16018', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '76301', 'city': 'Wichita Falls', 'state': 'Texas', 'country': 'United States', 'facility': 'Study Site 16241', 'geoPoint': {'lat': 33.91371, 'lon': -98.49339}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Study Site 17001', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '65929', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'Study Site 17014', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'zip': '10249', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Study Site 17005', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10967', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Study Site 17009', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Study Site 17003', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Study Site 17006', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Study Site 18001', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1134', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Study Site 18005', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4400', 'city': 'Nyíregyháza', 'country': 'Hungary', 'facility': 'Study Site 18007', 'geoPoint': {'lat': 47.95539, 'lon': 21.71671}}, {'zip': '7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Study Site 18003', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Study Site 18009', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '3109601', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Study Site 19005', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'zip': '22100', 'city': 'Nahariya', 'country': 'Israel', 'facility': 'Study Site 19002', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '13100', 'city': 'Safed', 'country': 'Israel', 'facility': 'Study Site 19008', 'geoPoint': {'lat': 32.96465, 'lon': 35.496}}, {'zip': '1815 JD', 'city': 'Alkmaar', 'country': 'Netherlands', 'facility': 'Study Site 21001', 'geoPoint': {'lat': 52.63167, 'lon': 4.74861}}, {'zip': '1091 AC', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Study Site 21006', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': '3818 TZ', 'city': 'Amsterfoort', 'country': 'Netherlands', 'facility': 'Study Site 21017'}, {'zip': '6525 EC', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Study Site 21008', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}], 'overallOfficials': [{'name': 'Danielle Duffy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}