Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT04847232
Status:
TERMINATED
Last Update Posted:
2025-06-18
First Post:
2021-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)
Sponsor:
Organization:
Raw JSON
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'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Salivary gland mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Short-bowel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal 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'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Accidental death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Catheter site haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Complication associated with device', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Device related thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Diverticulum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Duodenal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Erosive oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric mucosal lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric polyps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}, {'term': 'Gastrointestinal ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1348, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1338, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.1'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence of the Composite of Cardiac Event Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1341', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SZC (Active)', 'description': '5 g SZC QD to 15 g SZC QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'SZC Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.867', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.76', 'ciUpperLimit': '1.26', 'estimateComment': 'SZC relative to Placebo', 'statisticalMethod': 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Only subjects with non-missing S-K value at the 12 month visit included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Incidence of the Composite of Arrhythmia Related Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'OG000'}, {'value': '1341', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SZC (Active)', 'description': '5 g SZC QD to 15 g SZC QD'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'SZC Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.510', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.12', 'ciLowerLimit': '0.80', 'ciUpperLimit': '1.56', 'estimateComment': 'SZC relative to Placebo', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Test of HR = 1'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)', 'description': 'Incidence of the composite endpoint of hospitalization, intervention, emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. 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{'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55.8', 'spread': '13.3', 'groupId': 'BG000'}, {'value': '56.3', 'spread': '13.6', 'groupId': 'BG001'}, {'value': '56.1', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 yr ≤ Age < 51 yr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '442', 'groupId': 'BG000'}, {'value': '441', 'groupId': 'BG001'}, {'value': '883', 'groupId': 'BG002'}]}]}, {'title': '51 yr ≤ Age < 65 yr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '526', 'groupId': 'BG000'}, {'value': '509', 'groupId': 'BG001'}, {'value': '1035', 'groupId': 'BG002'}]}]}, {'title': '65 yr ≤ Age < 85 yr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '373', 'groupId': 'BG000'}, {'value': '378', 'groupId': 'BG001'}, {'value': '751', 'groupId': 'BG002'}]}]}, {'title': 'Age ≥ 85 yr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '498', 'groupId': 'BG000'}, {'value': '517', 'groupId': 'BG001'}, {'value': '1015', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '851', 'groupId': 'BG000'}, {'value': '824', 'groupId': 'BG001'}, {'value': '1675', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'AMERICAN INDIAN OR ALASKA NATIVE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '101', 'groupId': 'BG002'}]}]}, {'title': 'ASIAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '392', 'groupId': 'BG000'}, {'value': '389', 'groupId': 'BG001'}, {'value': '781', 'groupId': 'BG002'}]}]}, {'title': 'BLACK OR AFRICAN AMERICAN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '251', 'groupId': 'BG002'}]}]}, {'title': 'NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'WHITE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '688', 'groupId': 'BG000'}, {'value': '672', 'groupId': 'BG001'}, {'value': '1360', 'groupId': 'BG002'}]}]}, {'title': 'OTHER', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '161', 'groupId': 'BG002'}]}]}, {'title': 'NOT REPORTED', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1341', 'groupId': 'BG001'}, {'value': '2690', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'spKt/V', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1007', 'groupId': 'BG000'}, {'value': '994', 'groupId': 'BG001'}, {'value': '2001', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.48', 'spread': '0.39', 'groupId': 'BG000'}, {'value': '1.51', 'spread': '0.47', 'groupId': 'BG001'}, {'value': '1.49', 'spread': '0.43', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Dialysis adequacy, single-pool Kt/V. The parameter Kt/V is a measurement of the efficacy of a hemodialysis session. It identifies the effective removal of a specific solute (clearance K) resulting from a given treatment (characterized by time t) in each patient (with a specific volume of distribution V for the solute considered). Operationally, Kt/V is a dimensionless number.', 'unitOfMeasure': 'Dimensionless', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set; participants with a non-missing value.'}, {'title': 'Dialysis vintage', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '1349', 'groupId': 'BG000'}, {'value': '1337', 'groupId': 'BG001'}, {'value': '2686', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.01', 'spread': '5.41', 'groupId': 'BG000'}, {'value': '5.82', 'spread': '5.20', 'groupId': 'BG001'}, {'value': '5.92', 'spread': '5.31', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Time since first dialysis.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Full analysis set; participants with a non-missing value.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-04-19', 'size': 5829145, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-05T04:41', 'hasProtocol': True}, {'date': '2023-12-19', 'size': 696971, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-03-05T04:41', '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2690}}, 'statusModule': {'whyStopped': 'The event rate observed in the study continued to be below primary assumptions, so that the completion of the study within a reasonable timeframe was deemed very unlikely.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-17', 'studyFirstSubmitDate': '2021-04-08', 'resultsFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2021-04-14', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of the Composite of Cardiac Event Outcomes', 'timeFrame': 'From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)', 'description': 'Incidence of the composite endpoint of SCD, all stroke, or hospitalization/intervention/emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.'}], 'secondaryOutcomes': [{'measure': 'Normokalemia at 12 Months Post-randomization', 'timeFrame': 'Randomization to 12-Month Visit', 'description': 'Logistic regression analysis of whether a subject is Normokalemic (S-K of 4.0 - 5.5 mmol/L ) after the LIDI at the 12-month visit.'}, {'measure': 'Incidence of the Composite of Arrhythmia Related Events', 'timeFrame': 'From Randomization (Visit 4) up to week 129 (Randomized Study Intervention Phase)', 'description': 'Incidence of the composite endpoint of hospitalization, intervention, emergency department (ED) visit due to arrhythmias is analyzed based on Cox regression model with treatment and region as covariates. Patients with no events are censored at final clinical assessment, death, or disposition event.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Hyperkalemia', 'Cardiovascular Events', 'Atrial Fibrillation', 'Ventricular Tachycardia'], 'conditions': ['Hyperkalemia']}, 'referencesModule': {'references': [{'pmid': '40618849', 'type': 'DERIVED', 'citation': 'Fishbane S, Dember LM, Jadoul M, Kovesdy CP, Guzman N, Kordzakhia G, Lisovskaja V, Sekar P, Wessman P, Al-Shurbaji A, Herzog CA. The randomized DIALIZE-Outcomes trial evaluated sodium zirconium cyclosilicate in hemodialysis. Kidney Int. 2025 Oct;108(4):686-694. doi: 10.1016/j.kint.2025.06.016. Epub 2025 Jul 4.'}, {'pmid': '37230521', 'type': 'DERIVED', 'citation': 'Fishbane S, Jadoul M, Dember L, Kovesdy CP, Al-Shurbaji A, Lisovskaja V, Sekar P, Katona B, Guzman N, Herzog C. Evaluation of the effect of sodium zirconium cyclosilicate on arrhythmia-related cardiovascular outcomes in patients receiving chronic haemodialysis with hyperkalaemia: protocol for the multicentre, randomised, controlled DIALIZE-Outcomes study. BMJ Open. 2023 May 25;13(5):e071309. doi: 10.1136/bmjopen-2022-071309.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9487C00001&attachmentIdentifier=7bd2ebb1-fd15-4ffd-b33a-18d3d5a2dca1&fileName=D9487C00001_-_Redacted_CSP.pdf&versionIdentifier=', 'label': 'Redacted CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9487C00001&attachmentIdentifier=ad595187-fc73-4fb0-9926-63b53fddc652&fileName=D9487C00001_-_Statistical_Analysis_Plan_-_Redacted.pdf&versionIdentifier=', 'label': 'Statistical Analysis Plan - Redacted'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9487C00001&attachmentIdentifier=a726e622-6a0f-4d71-b0f7-711400766969&fileName=D9487C00001_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'D9487C00001\\_CSR Synopsis\\_Redacted'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of Sodium Zirconium Cyclosilicate (SZC) on arrhythmia-related cardiovascular outcomes in participants on chronic hemodialysis with recurrent hyperkalemia.', 'detailedDescription': 'This is an international, multicenter, event-driven, randomized, double-blind, parallel group, placebo-controlled study, evaluating the utility of SZC versus placebo to reduce the incidence of sudden cardiac death (SCD), stroke, and arrhythmia-related hospitalizations, interventions, and emergency department (ED) visits in participants on chronic hemodialysis with recurrent hyperkalemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '130 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses\n3. Must be ≥ 18 years of age, at the time of signing the ICF.\n4. Receiving hemodialysis (or hemodiafiltration) 3 times a week for treatment of ESRD for ≥ 4 months before enrollment\n5. Must have hemodialysis access consisting of an arteriovenous fistula, arteriovenous graft, or tunneled (permanent) catheter which is expected to remain in place for the entire duration of the study\n6. At least 2 out of 3 pre-dialysis S K ≥ 5.5 mmol/L after the LIDI during screening\n7. Negative pregnancy test for female participants of childbearing potential\n8. Female participants must be 1 year postmenopausal, surgically sterile, or using one highly effective form of birth control (defined as one that can achieve a failure rate of less than 1% per year when used consistently and correctly). They should have been stable on their chosen method of birth control for a minimum of 3 months before entering the study and willing to remain on the birth control until 12 weeks after the last dose\n\nExclusion Criteria:\n\n1. Pseudohyperkalemia secondary to hemolyzed blood specimen (this situation is not considered screening failure, sampling or full screening can be postponed to a later time as applicable)\n2. Presence of cardiac arrhythmias or conduction defects that require immediate treatment\n3. Participants who have a pacemaker or implantable cardiac defibrillator\n4. Any medical condition, including active, clinically significant infection or liver disease, that in the opinion of the investigator or sponsor may pose a safety risk to a participant in this study, confound safety or efficacy assessment and jeopardize the quality of the data, or interfere with study participation, or any other restrictions or contraindications in the local prescribing information for SZC\n5. History of QT prolongation associated with other medications that required discontinuation of that medication\n6. Congenital long QT syndrome\n7. QTcF \\> 550 msec\n8. Atrial fibrillation requiring immediate/urgent intervention at screening or randomizations\n9. Treated with sodium polystyrene sulfonate (SPS, Kayexalate, Resonium), calcium polystyrene sulfonate (CPS Resonium Calcium), patiromer (Veltassa), or SZC (Lokelma) within 7 days before screening or anticipated requiring chronic use of any of these agents during the study. If participant requires rescue therapy (potassium binder or dialysate S-K change during screening period), the participant will be screen failed\n10. Participation in another clinical study with an investigational product, device, or non-standard hemodialysis procedure administered within one month before screening\n11. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)\n12. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements\n13. Previous randomization in the present study\n14. Females who are pregnant (confirmed with positive pregnancy test or a uterine ultrasound if pregnancy test result is questionable), breastfeeding, or planning to become pregnant during the study\n15. Known hypersensitivity or previous anaphylaxis to SZC or to components thereof\n16. Scheduled date for living donor kidney transplant\n17. Sustained Ventricular Tachycardia \\> 30 seconds requiring assessment / intervention'}, 'identificationModule': {'nctId': 'NCT04847232', 'briefTitle': 'Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'An International, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Sodium Zirconium Cyclosilicate on Arrythmia-related Cardiovascular Outcomes in Participants on Chronic Hemodialysis With Recurrent Hyperkalemia (DIALIZE-Outcomes)', 'orgStudyIdInfo': {'id': 'D9487C00001'}, 'secondaryIdInfos': [{'id': '2020-005561-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Zirconium Cyclosilicate', 'interventionNames': ['Drug: Sodium Zirconium Cyclosilicate (SZC)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: SZC Placebo']}], 'interventions': [{'name': 'Sodium Zirconium Cyclosilicate (SZC)', 'type': 'DRUG', 'otherNames': ['Lokelma TM'], 'description': 'Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. Afterward, the dose is adjusted monthly (or more frequent based on clinical judgment) depending on the current potassium value as measured after the long interdialytic interval (LIDI).', 'armGroupLabels': ['Sodium Zirconium Cyclosilicate']}, {'name': 'SZC Placebo', 'type': 'DRUG', 'description': 'Powder for oral suspension in a sachet. A dose is titrated in 5 g increments during a period of 4 weeks from 5 g up to 15 g qd on non-dialysis days. 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