Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT03608033
Status:
TERMINATED
Last Update Posted:
2025-12-09
First Post:
2018-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D005922', 'term': 'Glomerulonephritis, IGA'}, {'id': 'D011507', 'term': 'Proteinuria'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000718989', 'term': 'narsoplimab'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinfo@omeros.com', 'phone': '206-676-5000', 'title': 'Skylar Liles', 'organization': 'Omeros'}, 'certainAgreement': {'otherDetails': 'All PIs are restricted from publishing the results of the study until after sponsor publishes or 18 months after end of study at all sites. Sponsor requires removal of confidential information', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The Adverse Event period of time was from the date of Consent to up to 112 weeks (includes Screen and Run-in) or end of study visit', 'description': 'Treatment-emergent AEs are assessed throughout the study from first dose up to 96 weeks or end of study visit. Treatment-emergent AEs during blinded phase are displayed separately from Open-label phase.', 'eventGroups': [{'id': 'EG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 137, 'seriousNumAtRisk': 181, 'deathsNumAffected': 0, 'seriousNumAffected': 22}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution', 'otherNumAtRisk': 179, 'deathsNumAtRisk': 179, 'otherNumAffected': 121, 'seriousNumAtRisk': 179, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Open-Label OMS721', 'description': 'Subgroup of patients from blinded (either treatment group) who subsequently received open-label OMS721 during the open-label period\n\nOMS721: Biological: OMS721', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 25, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 38}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 49}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 73}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 14}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 7}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 29}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 40}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 8}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 36}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 23}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'AE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 4}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'SAE by System Organ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 181, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 179, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in 24-hour UPE in g/Day Compared to Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.3', 'spread': '0.0672', 'groupId': 'OG000'}, {'value': '-16.6', 'spread': '0.0680', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '36 Weeks', 'description': 'The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The prespecified Primary Interim Analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. The study was terminated after the Primary Analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Annualized eGFR Compared to Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721 (High Baseline Proteinuria Group)', 'description': 'High-risk Proteinuria Patients; 24-hour UPE ≥ 2 g/Day\n\nBiological: OMS721'}, {'id': 'OG001', 'title': 'Placebo (High Baseline Proteinuria Group)', 'description': 'High-risk Proteinuria Patients; 24-hour UPE ≥ 2 g/Day\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '-7.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 Weeks', 'description': 'The Rate of Change in eGFR up to 96 Weeks from Baseline in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/Day)', 'unitOfMeasure': 'mL/min/1.73 m²/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The prespecified secondary outcome analysis was in patients who had a 24-hour UPE ≥ 2 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Annualized eGFR Compared to Baseline in All Patients.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'OG000'}, {'value': '178', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Placebo\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-7.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '96 Weeks', 'description': 'The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE \\> 1 g/Day)', 'unitOfMeasure': 'mL/min/1.73 m²/year', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The prespecified secondary outcome analysis was in patients who had a 24-hour UPE \\> 1 g/day at baseline. Since the study was terminated early, not all patients reached week 96, therefore the last observation was carried forward for analysis.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour UPE in g/Day Compared to Baseline in All Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '132', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '-14.2', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-10.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 Weeks', 'description': 'Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE \\> 1 g/Day)', 'unitOfMeasure': 'g/ 24hrs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome data for this secondary outcome measure are available for a subset of 260 of the 360 participants (132 OMS721 and 128 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on these measures could provide inaccurate and/or misleading information.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721 (High-risk Proteinuria Group)', 'description': 'Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)\n\nAdministration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo (High-risk Proteinuria Group)', 'description': 'Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)\n\nAdministration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks and 48 weeks', 'description': 'Change From Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)', 'unitOfMeasure': 'g/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data for this secondary outcome measure are available for a subset of 131 of the 180 participants (66 OMS721 and 65 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721 (High-risk Proteinuria Group)', 'description': 'Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)\n\nAdministration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo (High-risk Proteinuria Group)', 'description': 'Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)\n\nAdministration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '11.6', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks and 72 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 72 Weeks in Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)', 'unitOfMeasure': 'g/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data for this secondary outcome measure are available for a subset of 121 of the 180 participants (60 OMS721 and 61 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks and 48 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population', 'unitOfMeasure': 'g/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data for this secondary outcome measure are available for a subset of 229 of the 360 participants (118 OMS721 and 111 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.'}, {'type': 'SECONDARY', 'title': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '36 weeks and 72 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population', 'unitOfMeasure': 'g/24hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Outcome measure data for this secondary outcome measure are available for a subset of 203 of the 360 participants (103 OMS721 and 100 placebo). These data are presented. Because the data collected up to the time of study termination for this outcome measure are incomplete, reliance on the data could provide inaccurate and/or misleading information.'}, {'type': 'SECONDARY', 'title': 'Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'classes': [{'categories': [{'measurements': [{'value': '181', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 112', 'description': 'As assessed by the incidence of adverse events through study completion (Week 112) in the patient group in the all-patients population. Clinically meaningful abnormalities in vital signs, clinical laboratory tests, and ECGs were collected as AEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Any patient who received study drug (N=360)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}], 'periods': [{'title': 'Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '181'}, {'groupId': 'FG001', 'numSubjects': '179'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '140'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '45'}]}, {'type': 'Study terminated by sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '68'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Period: OMS721', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Study Terminated By Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Patients with 24-hour UPE \\> 2 g/day at baseline will be allowed to receive 12-weeks of open-label active drug (OMS721) on Week 72 (18 months post randomization), provided they meet certain criteria:\n\n* Less than 30% reduction in UPE at the OL assessment visit from baseline UPE\n* Proteinuria is ≥ 3.0 g/day at 72 weeks from randomization, confirmed by 2 measurements at least 2 weeks apart, but \\< 3 weeks\n* Worsening renal function, defined as a decline in eGFR of \\> 5 mL/min/m\\^2 from baseline'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'OMS721', 'description': 'Administration of OMS721\n\nOMS721: Biological: OMS721'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)\n\nVehicle (D5W or saline): 5% Dextrose in water or normal saline solution'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Mean (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.7', 'spread': '12.01', 'groupId': 'BG000'}, {'value': '41.6', 'spread': '12.76', 'groupId': 'BG001'}, {'value': '41.2', 'spread': '12.38', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '61', 'groupId': 'BG001'}, {'value': '128', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '157', 'groupId': 'BG000'}, {'value': '166', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '114', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '232', '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': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Child Bearing Potential, n (%)', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}, {'title': 'Not Applicable (Male Subjects)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '181', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '360', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '114', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Baseline Weight (kg)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '82.7', 'spread': '19.95', 'groupId': 'BG000'}, {'value': '82.5', 'spread': '22.39', 'groupId': 'BG001'}, {'value': '82.6', 'spread': '21.17', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two participants were treated with OMS721 without following appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in the analysis population. One participant in the placebo group was randomized but did not have weight collected.'}, {'title': 'Baseline Height (cm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '178', 'groupId': 'BG001'}, {'value': '357', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '170.8', 'spread': '9.39', 'groupId': 'BG000'}, {'value': '171.9', 'spread': '10.10', 'groupId': 'BG001'}, {'value': '171.4', 'spread': '9.75', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two participants were treated with OMS721 without appropriate randomization procedures resulting in major protocol deviations. Thus, these participants were not included in this analysis. One subject in the placebo group was randomized but did not have height collected.'}, {'title': 'Baseline BMI (kg/m^2)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.3', 'spread': '6.51', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '6.87', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '6.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}, {'title': 'Baseline Systolic Blood Pressure (mmHG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '125.7', 'spread': '10.13', 'groupId': 'BG000'}, {'value': '124.8', 'spread': '12.03', 'groupId': 'BG001'}, {'value': '125.3', 'spread': '11.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}, {'title': 'Baseline Diastolic Blood Pressure (mmHG)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '78.3', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '77.8', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '78.1', 'spread': '8.72', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}, {'title': 'Baseline Estimated Glomerular Filtration Rate (mL/min/SSA), n(%)', 'classes': [{'title': 'Greater than or equal to 30 and Less than or equal to 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}, {'title': 'Greater than 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '117', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}, {'title': 'Baseline Urine Protein Excretion Rate (mg/24hrs)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2780.5', 'spread': '1633.49', 'groupId': 'BG000'}, {'value': '2869.3', 'spread': '1802', 'groupId': 'BG001'}, {'value': '2824.9', 'spread': '1717.98', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/24hrs', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}, {'title': 'Baseline Urine Protein Creatinine Ratio', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '179', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.21', 'groupId': 'BG000'}, {'value': '2.1', 'spread': '1.19', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': '(g/g)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Two patients were not randomized correctly in accordance with protocol procedures resulting in major protocol deviations. The patients were assigned to a treatment arm before study drug was administered. Therefore, these participants were not included in this analysis.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-06-19', 'size': 2582641, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-08T17:41', 'hasProtocol': True}, {'date': '2023-09-14', 'size': 1133926, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-08T17:42', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Eligible patients will be randomized 1:1 to receive OMS721 or placebo'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 360}}, 'statusModule': {'whyStopped': 'IA did not meet the prespecified primary endpoint.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-25', 'studyFirstSubmitDate': '2018-06-21', 'resultsFirstSubmitDate': '2025-01-10', 'studyFirstSubmitQcDate': '2018-07-23', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-25', 'studyFirstPostDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in 24-hour UPE in g/Day Compared to Baseline', 'timeFrame': '36 Weeks', 'description': 'The Primary Endpoint of this Study is the Percent Change from Baseline in Log-transformed 24-hour UPE in g/Day at 36 Weeks in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/day.'}], 'secondaryOutcomes': [{'measure': 'Change in Annualized eGFR Compared to Baseline.', 'timeFrame': '96 Weeks', 'description': 'The Rate of Change in eGFR up to 96 Weeks from Baseline in Patients with High Baseline Proteinuria (High-risk Proteinuria Group; 24-hour UPE ≥ 2 g/Day)'}, {'measure': 'Change in Annualized eGFR Compared to Baseline in All Patients.', 'timeFrame': '96 Weeks', 'description': 'The Rate of Change in eGFR up to 96 Weeks from Baseline in the All-patients Population (24-hour UPE \\> 1 g/Day)'}, {'measure': 'Change in 24-hour UPE in g/Day Compared to Baseline in All Patients', 'timeFrame': '36 Weeks', 'description': 'Change From Baseline in Log-transformed 24-hour UPE at Week 36 in the All-patients Population. (24-hour UPE \\> 1 g/Day)'}, {'measure': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks.', 'timeFrame': '36 weeks and 48 weeks', 'description': 'Change From Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in Patients With ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)'}, {'measure': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in Patients With >= 2 g/Day UPE at Baseline (High-risk Proteinuria Group).', 'timeFrame': '36 weeks and 72 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 72 Weeks in Patients with ≥ 2 g/Day UPE at Baseline (High-risk Proteinuria Group)'}, {'measure': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 48 Weeks in All Patients', 'timeFrame': '36 weeks and 48 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE Between 36 Weeks and 48 Weeks in the All-patients Population'}, {'measure': 'Change in 24-hour UPE in g/Day Between 36 Weeks and 72 Weeks in All Patients', 'timeFrame': '36 weeks and 72 weeks', 'description': 'Time-averaged Change from Baseline in the Log-transformed 24-hour UPE between 36 Weeks and 72 Weeks in the All-patients Population'}, {'measure': 'Safety and Tolerability of Narsoplimab for the Treatment of IgAN as Assessed by AEs, Vital Signs, Clinical Laboratory Tests, and ECGs', 'timeFrame': 'Week 112', 'description': 'As assessed by the incidence of adverse events through study completion (Week 112) in the patient group in the all-patients population. Clinically meaningful abnormalities in vital signs, clinical laboratory tests, and ECGs were collected as AEs.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IgA nephropathy', 'IgAN', 'Proteinuria', 'Chronic kidney disease', 'IgAN autoantibodies', 'eGFR', 'EGFR slope', 'UPE', 'Narsoplimab'], 'conditions': ['IgA Nephropathy']}, 'referencesModule': {'references': [{'pmid': '37772889', 'type': 'DERIVED', 'citation': 'El Karoui K, Fervenza FC, De Vriese AS. Treatment of IgA Nephropathy: A Rapidly Evolving Field. J Am Soc Nephrol. 2024 Jan 1;35(1):103-116. doi: 10.1681/ASN.0000000000000242. Epub 2023 Sep 29.'}, {'pmid': '35675911', 'type': 'DERIVED', 'citation': 'Reich HN, Floege J. How I Treat IgA Nephropathy. Clin J Am Soc Nephrol. 2022 Aug;17(8):1243-1246. doi: 10.2215/CJN.02710322. Epub 2022 Jun 8. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the effect of OMS721 on 24-hour urine protein excretion (UPE) in IgA nephropathy (IgAN) patients with high baseline proteinuria (high-risk proteinuria group; 24-hour UPE ≥ 2 g/day) assessed at 36 weeks from baseline.', 'detailedDescription': 'This is a Phase 3, double-blind, randomized, placebo-controlled, study in patients aged 18 years and above with a biopsy-confirmed diagnosis of IgAN and with 24-hour UPE that is \\> 1 g/day. The purpose of this study is to evaluate the efficacy and safety of narsoplimab (OMS721) compared to placebo on proteinuria and whether narsoplimab has the ability to slow disease progression in primary IgAN patients. The primary objective of the study is to evaluate proteinuria reduction as assessed by 24-hour UPE at 36 weeks from baseline. The trial will continue beyond 36 weeks in a blinded fashion to provide confirmatory evidence of long-term efficacy based on the annualized slope of eGFR over 24 months. The trial will enroll approximately 450 patients with 225 patients per arm, all having biopsy-proven IgAN with eGFR≥30 mL/min/1.73m\\^2 and 24 hour UPE \\>1g/day. The study duration for each patient is expected to last approximately 112 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older at the onset of Screening\n* Biopsy confirmed diagnosis of IgAN within 8 years prior to Screening or Run-in Visit 1\n* Documented history of proteinuria of \\> 1 g/day within 6 months prior to Screening or uPCR \\> 0.75 by spot urine at Screening\n* Mean of two proteinuria measurements \\> 1 g/day at baseline\n* Estimated glomerular filtration rate of ≥ 30 mL/min/1.73 m² at Screening and baseline\n\nExclusion Criteria:\n\n* Treatment with immunosuppressants (e.g., azathioprine or cyclophosphamide), Chinese traditional medicine with immunosuppressive function, cytotoxic drugs, or eculizumab within 8 weeks prior to Screening, unless such treatment is given for indications other than IgA.\n* Treatment with systemic corticosteroids within 8 weeks prior to Screening\n* Uncontrolled BP, a systolic BP of \\> 150 mmHg and a diastolic BP of \\> 100 mmHg at rest despite the combination of two or more anti-hypertensives including ACE inhibitors, ARBs, or direct renin inhibitors\n* Female patients who are pregnant, breast feeding, or planning to become pregnant up through 12 weeks after the last dose of study drug, including possible retreatments. Males who are planning to father children up through 12 weeks after the last dose of study drug, including possible retreatments\n* Clinical or biological evidence of Type 1 diabetes mellitus (DM), or poorly controlled DM with hemoglobin A1c \\> 7.5 or with evidence of diabetic nephropathy on biopsy, systemic lupus erythematosus, IgA vasculitis (Henoch-Schonlein purpura), secondary IgAN, or other renal disease during Screening and Run-In\n* Presence of significant morbidity or other major illness or disease that may confound the interpretation of the clinical trial results or may result in death within 2 years of Screening\n* History of renal transplantation\n* Have a known hypersensitivity to any constituent of the investigational product\n* Rapidly progressive glomerulonephritis, defined as a fall in eGFR of \\> 30 mL/min/1.73 m\\^2 within 24 weeks or \\> 15 mL/min/1.73 m\\^2 within 12 weeks prior to Screening\n* Significant abnormalities in clinical laboratory values\n* History of human immunodeficiency virus (HIV), evidence of immune suppression, active hepatitis C virus (HCV) infection (patients with positive anti-HCV antibody but a non-detected HCV RNA PCR can enroll), hepatitis B virus (HBV) infection (patients with positive HBsAg are excluded; for patients with isolated positive anti-HBc antibody, HBV DNA test by PCR must be non-detectable to enroll).\n* Diagnosis of a malignancy except for adequately treated and cured basal or squamous cell skin cancer, curatively treated in situ disease, or other cancer from which the patient has been disease-free for ≥ 5 years\n* Have received any other investigational drug or device or experimental procedures within 30 days of the Screening Visit (SV) or within 5 times the plasma half-life of the administered experimental drug, whichever is longer\n* Initiation or change in dosing of sodium glucose co-transporter 2 inhibitors (SGLT2i) during Screening and Run-In Periods. However, a stable dose regimen established at least 8 weeks prior to screening is acceptable\n* Treatment with Tarpeyo™ (budesonide) or other approved treatments for IgAN within 6 months prior to screening. Treatment with Tarpeyo is not allowed during Screening and Run-In Periods\n* Treatment with Kerendia® (finerenone) within 6 months prior to screening. Treatment with Kerendia is not allowed during Screening and Run-In Periods\n* Initiation of treatment with Filspari™ (sparsentan), a dual Endothelin Angiotensin Receptor Antagonist (dEARA) or similar medication within three months prior to screening. A stable dose initiated at minimum 3 months before screening is acceptable and will take the place of ACEi/ARB as background therapy'}, 'identificationModule': {'nctId': 'NCT03608033', 'briefTitle': 'Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Omeros Corporation'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Safety and Efficacy of OMS721 in Patients With Immunoglobulin A (IgA) Nephropathy (ARTEMIS - IGAN)', 'orgStudyIdInfo': {'id': 'OMS721-IGA-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OMS721', 'description': 'Administration of OMS721', 'interventionNames': ['Biological: OMS721']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Administration of Vehicle (D5W or Saline Solution)', 'interventionNames': ['Other: Vehicle (D5W or saline)']}], 'interventions': [{'name': 'OMS721', 'type': 'BIOLOGICAL', 'description': 'Biological: OMS721', 'armGroupLabels': ['OMS721']}, {'name': 'Vehicle (D5W or saline)', 'type': 'OTHER', 'description': '5% Dextrose in water or normal saline solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35630', 'city': 'Florence', 'state': 'Alabama', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 34.79981, 'lon': -87.67725}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Omeros Investigation Sites', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '90022-4302', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91324', 'city': 'Northridge', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 34.22834, 'lon': -118.53675}}, {'zip': '91773', 'city': 'San Dimas', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 34.10668, 'lon': -117.80673}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '90509', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '80230', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '30046', 'city': 'Lawrenceville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 33.95621, 'lon': -83.98796}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01107', 'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'zip': '55414', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '11365', 'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.73482, 'lon': -73.79347}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '3300', 'city': 'Posadas', 'state': 'Misiones Province', 'country': 'Argentina', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -27.39184, 'lon': -55.92379}}, {'zip': 'C1280AEB', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'X5016KEH', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}, {'zip': '4400', 'city': 'Salta', 'country': 'Argentina', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -24.80645, 'lon': -65.41999}}, {'zip': '2606', 'city': 'Garran', 'state': 'Australian Capital Territory, Woden', 'country': 'Australia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -35.34206, 'lon': 149.10846}}, {'zip': '3021', 'city': 'Footscray', 'state': 'Saint Albans', 'country': 'Australia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -37.8, 'lon': 144.9}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '3168', 'city': 'Clayton', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': -37.91667, 'lon': 145.11667}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '1-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': '4000', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '4002', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': 'V5Z2M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'N6A545', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'M5G2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '128 08', 'city': 'Prague', 'state': 'Prague', 'country': 'Czechia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '68167', 'city': 'Mannheim', 'state': 'Baden-Wrttemberg', 'country': 'Germany', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'zip': '80336', 'city': 'München', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 48.69668, 'lon': 13.46314}}, {'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}, {'zip': '78052', 'city': 'Villingen-Schwenningen', 'country': 'Germany', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 48.06226, 'lon': 8.49358}}, {'zip': '57010', 'city': 'Thessaloniki', 'state': 'Pilea-Chortiatis', 'country': 'Greece', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '71110', 'city': 'Heraklion', 'country': 'Greece', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '71409', 'city': 'Heraklion', 'country': 'Greece', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.32787, 'lon': 25.14341}}, {'zip': '26504', 'city': 'Pátrai', 'country': 'Greece', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}, {'zip': 'H-6500', 'city': 'Baja', 'country': 'Hungary', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 46.18299, 'lon': 18.95307}}, {'zip': 'H-1097', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-9024', 'city': 'Győr', 'country': 'Hungary', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 47.68333, 'lon': 17.63512}}, {'zip': 'H-7624', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '500038', 'city': 'Hyderabad', 'state': 'Ameerpet', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '387001', 'city': 'Nadiād', 'state': 'Gujarat', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 22.69385, 'lon': 72.86157}}, {'zip': '590010', 'city': 'Belagavi', 'state': 'Karnataka', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 15.85212, 'lon': 74.50447}}, {'zip': '575001', 'city': 'Mangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 12.91723, 'lon': 74.85603}}, {'zip': '673008', 'city': 'Kozhikode', 'state': 'Kerala', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 11.24802, 'lon': 75.7804}}, {'zip': '110017', 'city': 'New Delhi', 'state': 'New India', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '302004', 'city': 'Jaipur', 'state': 'Rajasthan', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 26.91962, 'lon': 75.78781}}, {'zip': '500034', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500038', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '500082', 'city': 'Hyderabad', 'state': 'Telangana', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'zip': '160012', 'city': 'Chandigarh', 'country': 'India', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}, {'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'zip': '24127', 'city': 'Bergamo', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'zip': '84025', 'city': 'Eboli', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.61747, 'lon': 15.05693}}, {'zip': '98125', 'city': 'Messina', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}, {'zip': '20122', 'city': 'Milan', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '41124', 'city': 'Modena', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'zip': '43126', 'city': 'Parma', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 44.79935, 'lon': 10.32618}}, {'zip': '29121', 'city': 'Piacenza', 'country': 'Italy', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 45.05242, 'lon': 9.69342}}, {'zip': 'LT-50161', 'city': 'Kaunas', 'country': 'Lithuania', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 54.90156, 'lon': 23.90909}}, {'zip': 'LT-08661', 'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'zip': '92-213', 'city': 'Lodz', 'state': 'Todzi', 'country': 'Poland', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}, {'zip': '30-688', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '10-561', 'city': 'Olsztyn', 'country': 'Poland', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 53.78376, 'lon': 20.49272}}, {'zip': '04-749', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '97401', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '04011', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '13496', 'city': 'Seongnam', 'state': 'Geyonggi-do', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}, {'zip': '14068', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}, {'zip': '49241', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '21431', 'city': 'Incheon', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '05278', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07061', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '3722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '28702', 'city': 'Madrid', 'state': 'San Sebastian de Lost Reyes', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '04009', 'city': 'Almería', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 36.83814, 'lon': -2.45974}}, {'zip': '08025', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'zip': '25198', 'city': 'Lleida', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.61674, 'lon': 0.62218}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '46026', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'zip': '50009', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '500', 'city': 'Changhua', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}, {'zip': '97002', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}, {'zip': '824', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}, {'zip': '220', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'zip': '235', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}, {'city': 'Taichung', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}, {'zip': '333', 'city': 'Taoyuan', 'country': 'Taiwan', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}, {'zip': '10300', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '50200', 'city': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}, {'city': 'Dusit', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 13.7775, 'lon': 100.51977}}, {'zip': '40000', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '90000', 'city': 'Songkhla', 'country': 'Thailand', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 7.19882, 'lon': 100.5951}}, {'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '16059', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '22130', 'city': 'Edirne', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.67719, 'lon': 26.55597}}, {'zip': '34899', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '41380', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'zip': '44200', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}, {'zip': 'LE5 4PW', 'city': 'Leicester', 'state': 'Evington', 'country': 'United Kingdom', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CF10 3XQ', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'DA2 8DA', 'city': 'Dartford', 'country': 'United Kingdom', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.44657, 'lon': 0.21423}}, {'zip': 'NW3 2QG', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Omeros Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Omeros Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}