Viewing Study NCT04419467

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Ignite Creation Date: 2025-12-25 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
Study NCT ID: NCT04419467
Status: COMPLETED
Last Update Posted: 2023-12-06
First Post: 2020-06-03
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-11-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@cslbehring.com', 'phone': '610-878-4000', 'title': 'Study Director', 'organization': 'CSL Behring'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': "Adverse Event data are presented for the Treatment Period (12 weeks) and the Follow-up Period (up to 12 weeks after the participant's last dose of Investigational Product in the Treatment Period).", 'description': 'Adverse Event data are presented for the Safety Analysis Set.', 'eventGroups': [{'id': 'EG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 17, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 11, 'seriousNumAtRisk': 29, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 18, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Tooth infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'C-reactive protein increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Injection site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Albuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'seriousEvents': [{'term': 'Campylobacter gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Subdural abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Traumatic fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Dyspnoea exertional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Paroxysmal atrioventricular block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Brain natriuretic peptide increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Glomerular filtration rate decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Albuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 54, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions Placebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '-9.79', 'upperLimit': '18.05'}, {'value': '17.7', 'groupId': 'OG001', 'lowerLimit': '2.54', 'upperLimit': '35.18'}, {'value': '5.4', 'groupId': 'OG002', 'lowerLimit': '-3.24', 'upperLimit': '14.91'}]}]}], 'analyses': [{'pValue': '0.485', 'groupIds': ['OG000', 'OG002'], 'paramType': 'GM % treatment difference (80% CI)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '-0.5', 'ciLowerLimit': '-14.8', 'ciUpperLimit': '16.3', 'pValueComment': 'One-sided p-value', 'estimateComment': 'Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean (GM), then expressed as percent treatment difference.', 'statisticalMethod': 'Mixed Models Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.750', 'groupIds': ['OG001', 'OG002'], 'paramType': 'GM % treatment difference (80% CI)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '80', 'paramValue': '8.6', 'ciLowerLimit': '-7.2', 'ciUpperLimit': '27.2', 'pValueComment': 'One-sided p-value', 'estimateComment': 'Data analyzed are log-transformed values of ACR, using MMRM. Comparisons vs. placebo are back-transformed by exponentiation to obtain geometric mean, then expressed as percent treatment difference', 'statisticalMethod': 'Mixed Models Repeated Measures Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline up to Week 16', 'description': 'Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.', 'unitOfMeasure': 'Geometric Mean of Percent Change', 'dispersionType': '80% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '75.9', 'groupId': 'OG000'}, {'value': '79.3', 'groupId': 'OG001'}, {'value': '59.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 weeks', 'description': 'Data are presented for treatment-emergent AESIs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With AESIs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}], 'classes': [{'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000'}, {'value': '20.7', 'groupId': 'OG001'}, {'value': '24.1', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 weeks', 'description': 'Data are presented for treatment-emergent AESIs.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Observed Value and Mean Change From Baseline in Serum Creatinine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG001', 'title': 'CSL346 (Low Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG002', 'title': 'CSL346 (High Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG003', 'title': 'CSL346 (High Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG004', 'title': 'Placebo - Observed', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Observed value.'}, {'id': 'OG005', 'title': 'Placebo - Change', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Change from Baseline.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.273', 'spread': '0.5502', 'groupId': 'OG000'}, {'value': '1.321', 'spread': '0.5592', 'groupId': 'OG002'}, {'value': '1.207', 'spread': '0.5184', 'groupId': 'OG004'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.306', 'spread': '0.5374', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1900', 'groupId': 'OG001'}, {'value': '1.269', 'spread': '0.5049', 'groupId': 'OG002'}, {'value': '-0.052', 'spread': '0.1687', 'groupId': 'OG003'}, {'value': '1.203', 'spread': '0.5163', 'groupId': 'OG004'}, {'value': '-0.012', 'spread': '0.1057', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.306', 'spread': '0.5229', 'groupId': 'OG000'}, {'value': '0.032', 'spread': '0.1634', 'groupId': 'OG001'}, {'value': '1.218', 'spread': '0.4838', 'groupId': 'OG002'}, {'value': '-0.079', 'spread': '0.1838', 'groupId': 'OG003'}, {'value': '1.234', 'spread': '0.5318', 'groupId': 'OG004'}, {'value': '0.013', 'spread': '0.1080', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.316', 'spread': '0.6564', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.3106', 'groupId': 'OG001'}, {'value': '1.290', 'spread': '0.5247', 'groupId': 'OG002'}, {'value': '-0.030', 'spread': '0.1956', 'groupId': 'OG003'}, {'value': '1.229', 'spread': '0.5427', 'groupId': 'OG004'}, {'value': '0.014', 'spread': '0.1060', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.292', 'spread': '0.6252', 'groupId': 'OG000'}, {'value': '0.034', 'spread': '0.1377', 'groupId': 'OG001'}, {'value': '1.265', 'spread': '0.5514', 'groupId': 'OG002'}, {'value': '-0.056', 'spread': '0.1096', 'groupId': 'OG003'}, {'value': '1.200', 'spread': '0.4977', 'groupId': 'OG004'}, {'value': '0.017', 'spread': '0.1516', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.285', 'spread': '0.5621', 'groupId': 'OG000'}, {'value': '0.025', 'spread': '0.1725', 'groupId': 'OG001'}, {'value': '1.226', 'spread': '0.4711', 'groupId': 'OG002'}, {'value': '-0.050', 'spread': '0.2002', 'groupId': 'OG003'}, {'value': '1.251', 'spread': '0.5409', 'groupId': 'OG004'}, {'value': '0.030', 'spread': '0.1371', 'groupId': 'OG005'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.243', 'spread': '0.5404', 'groupId': 'OG000'}, {'value': '-0.017', 'spread': '0.1859', 'groupId': 'OG001'}, {'value': '1.226', 'spread': '0.5367', 'groupId': 'OG002'}, {'value': '-0.051', 'spread': '0.0985', 'groupId': 'OG003'}, {'value': '1.243', 'spread': '0.5169', 'groupId': 'OG004'}, {'value': '0.019', 'spread': '0.1361', 'groupId': 'OG005'}]}]}, {'title': 'Day 169, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '1.295', 'spread': '0.6468', 'groupId': 'OG000'}, {'value': '0.043', 'spread': '0.2242', 'groupId': 'OG001'}, {'value': '1.284', 'spread': '0.5878', 'groupId': 'OG002'}, {'value': '-0.032', 'spread': '0.1839', 'groupId': 'OG003'}, {'value': '1.280', 'spread': '0.5169', 'groupId': 'OG004'}, {'value': '0.026', 'spread': '0.1370', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG001', 'title': 'CSL346 (Low Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG002', 'title': 'CSL346 (High Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG003', 'title': 'CSL346 (High Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG004', 'title': 'Placebo - Observed', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Observed value.'}, {'id': 'OG005', 'title': 'Placebo - Change', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Change from Baseline.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '65.38', 'spread': '25.691', 'groupId': 'OG000'}, {'value': '64.94', 'spread': '27.960', 'groupId': 'OG002'}, {'value': '71.95', 'spread': '28.186', 'groupId': 'OG004'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '63.62', 'spread': '26.433', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '9.218', 'groupId': 'OG001'}, {'value': '66.31', 'spread': '27.442', 'groupId': 'OG002'}, {'value': '1.37', 'spread': '7.400', 'groupId': 'OG003'}, {'value': '72.57', 'spread': '28.443', 'groupId': 'OG004'}, {'value': '1.13', 'spread': '5.947', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '63.02', 'spread': '25.313', 'groupId': 'OG000'}, {'value': '-2.36', 'spread': '8.119', 'groupId': 'OG001'}, {'value': '69.15', 'spread': '28.175', 'groupId': 'OG002'}, {'value': '3.09', 'spread': '9.005', 'groupId': 'OG003'}, {'value': '70.47', 'spread': '28.419', 'groupId': 'OG004'}, {'value': '-0.68', 'spread': '7.230', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '65.74', 'spread': '27.747', 'groupId': 'OG000'}, {'value': '0.35', 'spread': '10.433', 'groupId': 'OG001'}, {'value': '66.12', 'spread': '28.001', 'groupId': 'OG002'}, {'value': '1.18', 'spread': '7.296', 'groupId': 'OG003'}, {'value': '71.19', 'spread': '28.935', 'groupId': 'OG004'}, {'value': '-0.26', 'spread': '5.992', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}, {'value': '48', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '66.57', 'spread': '27.555', 'groupId': 'OG000'}, {'value': '-0.26', 'spread': '7.962', 'groupId': 'OG001'}, {'value': '67.55', 'spread': '28.026', 'groupId': 'OG002'}, {'value': '2.61', 'spread': '5.496', 'groupId': 'OG003'}, {'value': '71.98', 'spread': '28.075', 'groupId': 'OG004'}, {'value': '-0.56', 'spread': '7.175', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '64.33', 'spread': '24.940', 'groupId': 'OG000'}, {'value': '-1.75', 'spread': '9.425', 'groupId': 'OG001'}, {'value': '68.44', 'spread': '25.535', 'groupId': 'OG002'}, {'value': '1.00', 'spread': '7.818', 'groupId': 'OG003'}, {'value': '69.87', 'spread': '29.764', 'groupId': 'OG004'}, {'value': '-0.87', 'spread': '6.522', 'groupId': 'OG005'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '46', 'groupId': 'OG004'}, {'value': '46', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '66.80', 'spread': '26.168', 'groupId': 'OG000'}, {'value': '0.72', 'spread': '10.277', 'groupId': 'OG001'}, {'value': '69.77', 'spread': '27.114', 'groupId': 'OG002'}, {'value': '2.34', 'spread': '6.130', 'groupId': 'OG003'}, {'value': '69.91', 'spread': '28.493', 'groupId': 'OG004'}, {'value': '-0.32', 'spread': '6.673', 'groupId': 'OG005'}]}]}, {'title': 'Day 169, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '66.05', 'spread': '28.012', 'groupId': 'OG000'}, {'value': '-0.56', 'spread': '11.079', 'groupId': 'OG001'}, {'value': '67.89', 'spread': '28.783', 'groupId': 'OG002'}, {'value': '2.19', 'spread': '6.456', 'groupId': 'OG003'}, {'value': '67.70', 'spread': '28.158', 'groupId': 'OG004'}, {'value': '-1.67', 'spread': '6.474', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 weeks', 'unitOfMeasure': 'mL/min/1.73 m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Observed Value and Mean Change From Baseline in Systolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG001', 'title': 'CSL346 (Low Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG002', 'title': 'CSL346 (High Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG003', 'title': 'CSL346 (High Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG004', 'title': 'Placebo - Observed', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Observed value.'}, {'id': 'OG005', 'title': 'Placebo - Change', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Change from Baseline.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '133.4', 'spread': '10.61', 'groupId': 'OG000'}, {'value': '131.4', 'spread': '8.63', 'groupId': 'OG002'}, {'value': '133.9', 'spread': '11.32', 'groupId': 'OG004'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '135.1', 'spread': '14.21', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '12.58', 'groupId': 'OG001'}, {'value': '133.9', 'spread': '9.17', 'groupId': 'OG002'}, {'value': '2.6', 'spread': '7.37', 'groupId': 'OG003'}, {'value': '135.7', 'spread': '11.31', 'groupId': 'OG004'}, {'value': '1.6', 'spread': '12.03', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '134.4', 'spread': '16.25', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '11.53', 'groupId': 'OG001'}, {'value': '136.5', 'spread': '9.10', 'groupId': 'OG002'}, {'value': '4.4', 'spread': '8.41', 'groupId': 'OG003'}, {'value': '135.3', 'spread': '12.60', 'groupId': 'OG004'}, {'value': '1.0', 'spread': '12.82', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '135.7', 'spread': '11.16', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '9.02', 'groupId': 'OG001'}, {'value': '137.7', 'spread': '10.99', 'groupId': 'OG002'}, {'value': '6.3', 'spread': '11.55', 'groupId': 'OG003'}, {'value': '133.8', 'spread': '12.04', 'groupId': 'OG004'}, {'value': '-0.2', 'spread': '12.58', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '135.1', 'spread': '12.75', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '12.00', 'groupId': 'OG001'}, {'value': '134.7', 'spread': '13.93', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '12.44', 'groupId': 'OG003'}, {'value': '133.1', 'spread': '13.98', 'groupId': 'OG004'}, {'value': '-0.8', 'spread': '12.60', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '131.5', 'spread': '13.88', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '12.93', 'groupId': 'OG001'}, {'value': '134.9', 'spread': '10.69', 'groupId': 'OG002'}, {'value': '2.3', 'spread': '10.93', 'groupId': 'OG003'}, {'value': '135.7', 'spread': '14.99', 'groupId': 'OG004'}, {'value': '1.9', 'spread': '13.15', 'groupId': 'OG005'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '136.2', 'spread': '15.13', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '12.23', 'groupId': 'OG001'}, {'value': '136.9', 'spread': '8.45', 'groupId': 'OG002'}, {'value': '4.3', 'spread': '10.17', 'groupId': 'OG003'}, {'value': '133.5', 'spread': '12.93', 'groupId': 'OG004'}, {'value': '0.4', 'spread': '12.09', 'groupId': 'OG005'}]}]}, {'title': 'Day 169, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '141.0', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '10.55', 'groupId': 'OG001'}, {'value': '132.7', 'spread': '13.24', 'groupId': 'OG002'}, {'value': '1.0', 'spread': '12.20', 'groupId': 'OG003'}, {'value': '134.6', 'spread': '15.17', 'groupId': 'OG004'}, {'value': '1.1', 'spread': '16.51', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Observed Value and Mean Change From Baseline in Diastolic Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}, {'value': '56', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG001', 'title': 'CSL346 (Low Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG002', 'title': 'CSL346 (High Dose) - Observed', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Observed value.'}, {'id': 'OG003', 'title': 'CSL346 (High Dose) - Change', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody. Change from Baseline.'}, {'id': 'OG004', 'title': 'Placebo - Observed', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Observed value.'}, {'id': 'OG005', 'title': 'Placebo - Change', 'description': 'Administered as a single IV loading dose followed by SC infusions. Placebo: Normal saline. Change from Baseline.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '54', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '75.5', 'spread': '8.55', 'groupId': 'OG000'}, {'value': '73.4', 'spread': '11.22', 'groupId': 'OG002'}, {'value': '75.5', 'spread': '8.88', 'groupId': 'OG004'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '8.22', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '8.95', 'groupId': 'OG001'}, {'value': '75.4', 'spread': '11.00', 'groupId': 'OG002'}, {'value': '2.0', 'spread': '5.75', 'groupId': 'OG003'}, {'value': '75.3', 'spread': '9.73', 'groupId': 'OG004'}, {'value': '-0.3', 'spread': '7.94', 'groupId': 'OG005'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '51', 'groupId': 'OG004'}, {'value': '51', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '74.7', 'spread': '7.34', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '7.36', 'groupId': 'OG001'}, {'value': '77.2', 'spread': '10.75', 'groupId': 'OG002'}, {'value': '3.5', 'spread': '6.52', 'groupId': 'OG003'}, {'value': '74.4', 'spread': '8.99', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '6.84', 'groupId': 'OG005'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '53', 'groupId': 'OG004'}, {'value': '53', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '77.2', 'spread': '6.49', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '5.84', 'groupId': 'OG001'}, {'value': '78.0', 'spread': '8.58', 'groupId': 'OG002'}, {'value': '4.5', 'spread': '8.36', 'groupId': 'OG003'}, {'value': '75.0', 'spread': '9.01', 'groupId': 'OG004'}, {'value': '-0.6', 'spread': '8.17', 'groupId': 'OG005'}]}]}, {'title': 'Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}, {'value': '49', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '76.1', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '6.90', 'groupId': 'OG001'}, {'value': '76.8', 'spread': '9.74', 'groupId': 'OG002'}, {'value': '3.3', 'spread': '9.36', 'groupId': 'OG003'}, {'value': '72.6', 'spread': '9.96', 'groupId': 'OG004'}, {'value': '-2.5', 'spread': '7.58', 'groupId': 'OG005'}]}]}, {'title': 'Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '74.2', 'spread': '6.57', 'groupId': 'OG000'}, {'value': '-1.7', 'spread': '7.56', 'groupId': 'OG001'}, {'value': '77.3', 'spread': '11.00', 'groupId': 'OG002'}, {'value': '3.1', 'spread': '7.67', 'groupId': 'OG003'}, {'value': '73.3', 'spread': '10.19', 'groupId': 'OG004'}, {'value': '-1.5', 'spread': '7.88', 'groupId': 'OG005'}]}]}, {'title': 'Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '75.7', 'spread': '7.20', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '6.40', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '9.94', 'groupId': 'OG002'}, {'value': '3.6', 'spread': '7.01', 'groupId': 'OG003'}, {'value': '73.3', 'spread': '9.75', 'groupId': 'OG004'}, {'value': '-1.4', 'spread': '7.33', 'groupId': 'OG005'}]}]}, {'title': 'Day 169, End of Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '27', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}, {'value': '47', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '77.0', 'spread': '8.06', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.83', 'groupId': 'OG001'}, {'value': '76.0', 'spread': '11.00', 'groupId': 'OG002'}, {'value': '2.1', 'spread': '8.78', 'groupId': 'OG003'}, {'value': '73.7', 'spread': '10.88', 'groupId': 'OG004'}, {'value': '-1.0', 'spread': '8.19', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 24 weeks', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Analysis Set'}, {'type': 'SECONDARY', 'title': 'Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'categories': [{'measurements': [{'value': '234.26', 'spread': '671.392', 'groupId': 'OG000'}, {'value': '182.32', 'spread': '140.886', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 120 minutes after the IV loading dose for CSL346', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set'}, {'type': 'SECONDARY', 'title': 'Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.0'}, {'value': '0.55', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '2.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 120 minutes after the IV loading dose for CSL346', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'categories': [{'measurements': [{'value': '34.70', 'spread': '11.405', 'groupId': 'OG000'}, {'value': '67.88', 'spread': '29.565', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 29', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Tmax After First SC Dose of CSL346 in Serum Samples', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'categories': [{'measurements': [{'value': '168.05', 'groupId': 'OG000', 'lowerLimit': '119.1', 'upperLimit': '671.0'}, {'value': '167.58', 'groupId': 'OG001', 'lowerLimit': '118.1', 'upperLimit': '336.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From Day 1 to Day 29', 'unitOfMeasure': 'Hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Area Under the Concentration-time Curve in First Dosing Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'categories': [{'measurements': [{'value': '19374.474', 'spread': '5560.5651', 'groupId': 'OG000'}, {'value': '37225.571', 'spread': '13026.7980', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From Day 1 to Day 29', 'unitOfMeasure': 'Hours*ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Trough Concentration After Each Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'title': 'After first SC dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.306', 'spread': '5.9479', 'groupId': 'OG000'}, {'value': '28.215', 'spread': '9.6135', 'groupId': 'OG001'}]}]}, {'title': 'After second SC dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.686', 'spread': '7.0049', 'groupId': 'OG000'}, {'value': '31.541', 'spread': '9.3408', 'groupId': 'OG001'}]}]}, {'title': 'After third SC dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.959', 'spread': '8.1791', 'groupId': 'OG000'}, {'value': '31.522', 'spread': '10.1988', 'groupId': 'OG001'}]}]}, {'title': 'After fourth SC dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.225', 'spread': '6.2157', 'groupId': 'OG000'}, {'value': '30.544', 'spread': '10.6822', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '29 days after each dose', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Positive for Anti-drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Weeks 4, 8, and 16', 'description': 'Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Positive for Anti-drug Antibodies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions.\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'OG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions CSL346: VEGF-B antagonist monoclonal antibody'}], 'classes': [{'title': 'Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 4, 8, and 16', 'description': 'Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'FG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Not treated with IP', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Pandemic related', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Reason not known', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at study centers in Australia, Canada, Israel, New Zealand, Puerto Rico and the United States.', 'preAssignmentDetails': 'A total of 327 participants were screened, of which 114 participants met the eligibility criteria, completed the Lead-in Period and were randomized to receive CSL346 (low dose), CSL346 (high dose), or Placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'CSL346 (Low Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'BG001', 'title': 'CSL346 (High Dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions\n\nCSL346: VEGF-B antagonist monoclonal antibody'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions\n\nPlacebo: Normal saline'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.0', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '78'}, {'value': '61.0', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '84'}, {'value': '63.0', 'groupId': 'BG002', 'lowerLimit': '32', 'upperLimit': '85'}, {'value': '62.0', 'groupId': 'BG003', 'lowerLimit': '32', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '86', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '72', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'New Zealand', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}]}, {'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '64', 'groupId': 'BG003'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Intent-to-Treat Analysis Set'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-27', 'size': 17902110, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-24T04:31', 'hasProtocol': True}, {'date': '2022-09-29', 'size': 1287509, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-24T04:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 114}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2020-06-03', 'resultsFirstSubmitDate': '2023-10-24', 'studyFirstSubmitQcDate': '2020-06-03', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-05', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change From Baseline in Urinary Albumin-to-creatinine Ratio (ACR)', 'timeFrame': 'Baseline up to Week 16', 'description': 'Data are presented as the geometric mean (GM) of percent change, which is calculated as the geometric mean of the Week 16 ACR to baseline, expressed as percent change from baseline.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Percentage of Subjects With TEAEs', 'timeFrame': 'Up to 24 weeks'}, {'measure': 'Number of Subjects With Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Up to 24 weeks', 'description': 'Data are presented for treatment-emergent AESIs.'}, {'measure': 'Percentage of Subjects With AESIs', 'timeFrame': 'Up to 24 weeks', 'description': 'Data are presented for treatment-emergent AESIs.'}, {'measure': 'Observed Value and Mean Change From Baseline in Serum Creatinine', 'timeFrame': 'Baseline up to 24 weeks'}, {'measure': 'Observed Value and Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)', 'timeFrame': 'Baseline up to 24 weeks'}, {'measure': 'Observed Value and Mean Change From Baseline in Systolic Blood Pressure', 'timeFrame': 'Baseline up to 24 weeks'}, {'measure': 'Observed Value and Mean Change From Baseline in Diastolic Blood Pressure', 'timeFrame': 'Baseline up to 24 weeks'}, {'measure': 'Maximum Concentration (Cmax) After Intravenous (IV) Loading Dose of CSL346 in Serum Samples', 'timeFrame': 'Up to 120 minutes after the IV loading dose for CSL346'}, {'measure': 'Time to Reach Cmax in Serum (Tmax) After IV Loading Dose of CSL346 in Serum Samples', 'timeFrame': 'Up to 120 minutes after the IV loading dose for CSL346'}, {'measure': 'Cmax After First Subcutaneous (SC) Dose of CSL346 in Serum Samples', 'timeFrame': 'From Day 1 to Day 29'}, {'measure': 'Tmax After First SC Dose of CSL346 in Serum Samples', 'timeFrame': 'From Day 1 to Day 29'}, {'measure': 'Area Under the Concentration-time Curve in First Dosing Interval', 'timeFrame': 'From Day 1 to Day 29'}, {'measure': 'Trough Concentration After Each Dose', 'timeFrame': '29 days after each dose'}, {'measure': 'Number of Subjects Positive for Anti-drug Antibodies', 'timeFrame': 'Weeks 4, 8, and 16', 'description': 'Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.'}, {'measure': 'Percentage of Subjects Positive for Anti-drug Antibodies', 'timeFrame': 'Weeks 4, 8, and 16', 'description': 'Data are presented for participants who received treatment with CSL346. Any anti-drug antibodies detected in participants who received treatment with Placebo were considered not specific to CSL346 and of no clinical relevance.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Kidney Disease (DKD)']}, 'referencesModule': {'references': [{'pmid': '39150859', 'type': 'DERIVED', 'citation': 'Cooper M, Cherney DZI, Greene TH, Heerspink HJL, Jardine M, Lewis JB, Wong MG, Baquero E, Heise M, Jochems J, Lanchoney D, Liss C, Reiser D, Scotney P, Velkoska E, Dwyer JP. Vascular Endothelial Growth Factor-B Blockade with CSL346 in Diabetic Kidney Disease: A Phase 2A Randomized Controlled Trial. J Am Soc Nephrol. 2024 Nov 1;35(11):1546-1557. doi: 10.1681/ASN.0000000000000438. Epub 2024 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria receiving standard of care treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects ≥ 25 years of age with a diagnosis of type 2 diabetes mellitus (T2DM)\n* Urinary ACR ≥ 150 mg/g\n* eGFR \\> 20 mL/min/1.73m2\n* Glycosylated HbA1c \\< 12%\n\nExclusion Criteria:\n\n* Current diagnosis of type 1 diabetes mellitus\n* History of acute kidney injury or chronic dialysis/renal transplant\n* Uncontrolled hypertension or class III / IV heart failure\n* Left ventricular ejection fraction \\< 50% by echocardiogram\n* Troponin-I \\> the upper reference limit\n* b-type natriuretic peptide \\> 200 pg/mL\n* ALT \\> 2x the upper limit of normal'}, 'identificationModule': {'nctId': 'NCT04419467', 'briefTitle': 'Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'CSL Behring'}, 'officialTitle': 'A Phase 2a, Double-blind, Randomized, Placebo-controlled, Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease', 'orgStudyIdInfo': {'id': 'CSL346_2001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CSL346 (low dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions', 'interventionNames': ['Biological: CSL346']}, {'type': 'EXPERIMENTAL', 'label': 'CSL346 (high dose)', 'description': 'Administered as a single intravenous (IV) loading dose followed by subcutaneous (SC) infusions', 'interventionNames': ['Biological: CSL346']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administered as a single IV loading dose followed by SC infusions', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'CSL346', 'type': 'BIOLOGICAL', 'description': 'VEGF-B antagonist monoclonal antibody', 'armGroupLabels': ['CSL346 (high dose)', 'CSL346 (low dose)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Normal saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91702', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'California Kidney Specialists (CKS) - Citrus Office', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Valley Research - Fresno', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '90717', 'city': 'Lomita', 'state': 'California', 'country': 'United States', 'facility': 'Torrance Clinical Research (TCR) - Lomita', 'geoPoint': {'lat': 33.79224, 'lon': -118.31507}}, {'zip': '90260', 'city': 'Lynwood', 'state': 'California', 'country': 'United States', 'facility': 'Renal Medical Associate/NARI', 'geoPoint': {'lat': 33.93029, 'lon': -118.21146}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Amicis Research Center', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'California Medical Research Associates, Inc', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '92503', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Riverside Nephrology Group', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '34761', 'city': 'Ocoee', 'state': 'Florida', 'country': 'United States', 'facility': 'West Orange Endocrinology', 'geoPoint': {'lat': 28.56917, 'lon': -81.54396}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '70006', 'city': 'Metairie', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Omega Clinical Research', 'geoPoint': {'lat': 29.98409, 'lon': -90.15285}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Renal and Transplant Associates', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '65212', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'University of Missouri Health System', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '89148', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Palm Medical Group, LLC - Las Vegas', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '10301', 'city': 'Staten Island', 'state': 'New York', 'country': 'United States', 'facility': 'Center for Thyroid & Parathyroid Disorders', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Physicians East, P.A. - Endocrinology', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77040', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Juno Research, L.L.C.', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The Endocrine Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Renal Associates, P.A. - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78224', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Primary Care Providers of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78231', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes and Metabolism Specialists (DMS) - San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '2291', 'city': 'Merewether', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Hunter Diabetes Centre - The AIM Centre', 'geoPoint': {'lat': -32.94801, 'lon': 151.74325}}, {'zip': '3065', 'city': 'Fitzroy', 'state': 'Victoria', 'country': 'Australia', 'facility': "St Vincent's Hospital", 'geoPoint': {'lat': -37.79839, 'lon': 144.97833}}, {'zip': '3084', 'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Austin Hospital', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'zip': '3052', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '3021', 'city': 'St Albans', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Sunshine Hospital', 'geoPoint': {'lat': -37.74496, 'lon': 144.80049}}, {'zip': '5112', 'city': 'Elizabeth Vale', 'country': 'Australia', 'facility': 'Lyell McEwin Hospital', 'geoPoint': {'lat': -34.74857, 'lon': 138.66819}}, {'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': '1240130 - University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '76100', 'city': 'Rehovot', 'country': 'Israel', 'facility': '3760045 - Kaplan Medical Center', 'geoPoint': {'lat': 31.89421, 'lon': 34.81199}}, {'zip': '64239', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': '3760044 - Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '2025', 'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '8011', 'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Lipid and Diabetes Research Group', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'zip': '6140', 'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Endocrine Associates - Wellington', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}, {'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundación de Investigación', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}, {'zip': '00935', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'University of Puerto Rico - Puerto Rico Clinical and TRC', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CSL Behring'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.', 'ipdSharing': 'YES', 'description': 'CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.\n\nApplicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.\n\nIf the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.', 'accessCriteria': "Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee.\n\nAn IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee.\n\nThe requesting party must execute an appropriate data sharing agreement before IPD will be made available."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CSL Behring', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}