Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02107092
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2014-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006947', 'term': 'Hyperkalemia'}], 'ancestors': [{'id': 'D014883', 'term': 'Water-Electrolyte Imbalance'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597310', 'term': 'sodium zirconium cyclosilicate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'AstraZeneca Clinical Study Information Center', 'organization': 'ZS Pharma, Inc.'}, 'certainAgreement': {'otherDetails': 'ZS Pharma has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Eleven months', 'description': 'The Extended Dosing Phase Safety Population was defined as all subjects who received at least 1 Extended Dosing Phase dose administration with any post-baseline Extended Dosing Phase safety data.', 'eventGroups': [{'id': 'EG000', 'title': 'ZS (Sodium Zirconium Cyclosilicate) QD Extended Phase Dosing', 'description': 'ZS 10g QD starting dose increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g QOD if i-STAT potassium values increased to \\> 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.', 'otherNumAtRisk': 123, 'otherNumAffected': 82, 'seriousNumAtRisk': 123, 'seriousNumAffected': 24}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 10}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Seasonal allergy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Blood urea increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperlipidemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypomagnesaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dizzines', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 15}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Retinal artery occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gastritis haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Diabetic foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Lobar pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Morganella infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Patella fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Dry gangrene', 'stats': [{'groupId': 'EG000', 'numAtRisk': 123, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD', 'description': 'ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to \\> 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.'}], 'classes': [{'title': 'ED Study Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.875', 'groupId': 'OG000', 'lowerLimit': '0.802', 'upperLimit': '0.928'}]}]}, {'title': 'ED Study Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.822', 'groupId': 'OG000', 'lowerLimit': '0.741', 'upperLimit': '0.886'}]}]}, {'title': 'ED Study Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.797', 'groupId': 'OG000', 'lowerLimit': '0.713', 'upperLimit': '0.865'}]}]}, {'title': 'ED Study Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.862', 'groupId': 'OG000', 'lowerLimit': '0.786', 'upperLimit': '0.919'}]}]}, {'title': 'ED Study Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.848', 'groupId': 'OG000', 'lowerLimit': '0.768', 'upperLimit': '0.909'}]}]}, {'title': 'ED Study Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.793', 'groupId': 'OG000', 'lowerLimit': '0.705', 'upperLimit': '0.864'}]}]}, {'title': 'ED Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.796', 'groupId': 'OG000', 'lowerLimit': '0.708', 'upperLimit': '0.868'}]}]}, {'title': 'ED Study Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.766', 'groupId': 'OG000', 'lowerLimit': '0.675', 'upperLimit': '0.843'}]}]}, {'title': 'ED Study Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.807', 'groupId': 'OG000', 'lowerLimit': '0.709', 'upperLimit': '0.833'}]}]}, {'title': 'ED Study Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.798', 'groupId': 'OG000', 'lowerLimit': '0.696', 'upperLimit': '0.877'}]}]}, {'title': 'ED Study Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.815', 'groupId': 'OG000', 'lowerLimit': '0.713', 'upperLimit': '0.892'}]}]}, {'title': 'ED Study Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.771', 'groupId': 'OG000', 'lowerLimit': '0.656', 'upperLimit': '0.863'}]}]}, {'title': 'ED Study Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.809', 'groupId': 'OG000', 'lowerLimit': '0.695', 'upperLimit': '0.894'}]}]}, {'title': 'ED Day Study 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.846', 'groupId': 'OG000', 'lowerLimit': '0.735', 'upperLimit': '0.924'}]}]}, {'title': 'ED Study Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.778', 'groupId': 'OG000', 'lowerLimit': '0.655', 'upperLimit': '0.873'}]}]}, {'title': 'ED Study Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.833', 'groupId': 'OG000', 'lowerLimit': '0.715', 'upperLimit': '0.917'}]}]}, {'title': 'ED Study Day 309', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.828', 'groupId': 'OG000', 'lowerLimit': '0.706', 'upperLimit': '0.914'}]}]}, {'title': 'ED Study Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.843', 'groupId': 'OG000', 'lowerLimit': '0.714', 'upperLimit': '0.930'}]}]}, {'title': 'ED Study Day 337/Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.783', 'groupId': 'OG000', 'lowerLimit': '0.699', 'upperLimit': '0.853'}]}]}, {'title': 'ED Study Days 8-337 Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.883', 'groupId': 'OG000', 'lowerLimit': '0.812', 'upperLimit': '0.935'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 months', 'description': 'The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.'}, {'type': 'SECONDARY', 'title': 'Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD', 'description': 'ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to \\> 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.'}], 'classes': [{'title': 'ED Study Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.950', 'groupId': 'OG000', 'lowerLimit': '0.894', 'upperLimit': '0.981'}]}]}, {'title': 'ED Study Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.932', 'groupId': 'OG000', 'lowerLimit': '0.871', 'upperLimit': '0.970'}]}]}, {'title': 'ED Study Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.975', 'groupId': 'OG000', 'lowerLimit': '0.927', 'upperLimit': '0.995'}]}]}, {'title': 'ED Study Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '116', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.957', 'groupId': 'OG000', 'lowerLimit': '0.902', 'upperLimit': '0.986'}]}]}, {'title': 'ED Study Day 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.955', 'groupId': 'OG000', 'lowerLimit': '0.899', 'upperLimit': '0.985'}]}]}, {'title': 'ED Study Day 43', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.946', 'groupId': 'OG000', 'lowerLimit': '0.886', 'upperLimit': '0.980'}]}]}, {'title': 'ED Study Day 50', 'denoms': [{'units': 'Participants', 'counts': [{'value': '108', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.935', 'groupId': 'OG000', 'lowerLimit': '0.871', 'upperLimit': '0.974'}]}]}, {'title': 'ED Study Day 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.944', 'groupId': 'OG000', 'lowerLimit': '0.882', 'upperLimit': '0.979'}]}]}, {'title': 'ED Study Day 85', 'denoms': [{'units': 'Participants', 'counts': [{'value': '88', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.943', 'groupId': 'OG000', 'lowerLimit': '0.872', 'upperLimit': '0.981'}]}]}, {'title': 'ED Study Day 113', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.940', 'groupId': 'OG000', 'lowerLimit': '0.867', 'upperLimit': '0.980'}]}]}, {'title': 'ED Study Day 141', 'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.938', 'groupId': 'OG000', 'lowerLimit': '0.862', 'upperLimit': '0.980'}]}]}, {'title': 'ED Study Day 169', 'denoms': [{'units': 'Participants', 'counts': [{'value': '70', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.929', 'groupId': 'OG000', 'lowerLimit': '0.841', 'upperLimit': '0.976'}]}]}, {'title': 'ED Study Day 197', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.941', 'groupId': 'OG000', 'lowerLimit': '0.856', 'upperLimit': '0.984'}]}]}, {'title': 'ED Day Study 225', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.985', 'groupId': 'OG000', 'lowerLimit': '0.917', 'upperLimit': '1.000'}]}]}, {'title': 'ED Study Day 253', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.937', 'groupId': 'OG000', 'lowerLimit': '0.845', 'upperLimit': '0.982'}]}]}, {'title': 'ED Study Day 281', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.950', 'groupId': 'OG000', 'lowerLimit': '0.861', 'upperLimit': '0.990'}]}]}, {'title': 'ED Study Day 309', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.914', 'groupId': 'OG000', 'lowerLimit': '0.810', 'upperLimit': '0.971'}]}]}, {'title': 'ED Study Day 337', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.980', 'groupId': 'OG000', 'lowerLimit': '0.896', 'upperLimit': '1.000'}]}]}, {'title': 'ED Study Day 337/Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.942', 'groupId': 'OG000', 'lowerLimit': '0.884', 'upperLimit': '0.976'}]}]}, {'title': 'ED Study Days 8-337 Average', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.000', 'groupId': 'OG000', 'lowerLimit': '0.970', 'upperLimit': '1.000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '11 months', 'description': 'The proportions of subjects with average S-K values ≤ 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Entered Extended Dosing Phase, received study drug and had post baseline S-K values during the Extended Dosing Phase. The analysis population includes 121 subjects, where there is one subject who only had end-of-study post-baseline measurement and therefore was not presented in the participants analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD', 'description': 'ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to \\> 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '123'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '79'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}]}], 'dropWithdraws': [{'type': 'Miscellaneous', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Subject compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Hypo-or hyperkalemia', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Met ECG withdrawal criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'Expected progression of CKD', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}]}], 'recruitmentDetails': 'Participants took part in the study at 30 outpatient sites in the United States, Australia and South Africa from 10 May 2014 to 14 July 2015.', 'preAssignmentDetails': 'Participants that completed Study ZS-004 (NCT02088073) Extended Dosing (ED) Phase Study Day 29 Visit or discontinued Study ZS-004 during the ED Phase due to hypo- or hyperkalemia, had a mean i-STAT potassium value between 3.5 and 6.2 mmol/L, and were able to start dosing in Study ZS-004E within 2 days after the last dose of study drug in ZS-004.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Extended Dosing Phase: ZS (Sodium Zirconium Cyclosilicate) QD', 'description': 'ZS 10g QD starting dose. ZS dose was increased or decreased in increments/ decrements of 5g QD to maximum of 15g QD or minimum of 5g every other day (QOD) if i-STAT potassium values increased to \\> 5.5 mmol/L or decreased to between 3.0 and 3.4 mmol/L, respectively.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.7', 'spread': '12.29', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '51', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '107', 'groupId': 'BG000'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Study ZS-004 Acute Phase S-K baseline', 'classes': [{'categories': [{'title': '< 5.5 mmol/L', 'measurements': [{'value': '54', 'groupId': 'BG000'}]}, {'title': '5.5-< 6.0 mmol/L', 'measurements': [{'value': '53', 'groupId': 'BG000'}]}, {'title': '≥ 6.0 mmol/L', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Acute Phase S-K baseline of participants in Study ZS-004', 'unitOfMeasure': 'Participants'}, {'title': 'Acute Phase eGFR at baseline', 'classes': [{'categories': [{'title': '<60 mL/min', 'measurements': [{'value': '90', 'groupId': 'BG000'}]}, {'title': '≥ 60 mL/min', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Acute Phase baseline from Study ZS-004', 'unitOfMeasure': 'Participants'}, {'title': 'Cormordid conditions and concomitant medications which may contirubute to hyperkalemia', 'classes': [{'title': 'RAAS inhibitor medication', 'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}, {'title': 'Diabetes mellitus', 'categories': [{'measurements': [{'value': '80', 'groupId': 'BG000'}]}]}, {'title': 'Chronic kidney disease', 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG000'}]}]}, {'title': 'Heart failure', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Categories are not mutually exclusive', 'unitOfMeasure': 'Participants'}], 'populationDescription': '2 subjects did not have any S-K measurements during the ED phase due to early termination and are excluded from baseline characteristics'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 123}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'dispFirstSubmitDate': '2015-11-12', 'completionDateStruct': {'date': '2015-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-16', 'studyFirstSubmitDate': '2014-04-03', 'dispFirstSubmitQcDate': '2015-11-12', 'resultsFirstSubmitDate': '2017-07-13', 'studyFirstSubmitQcDate': '2014-04-03', 'dispFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-16', 'studyFirstPostDateStruct': {'date': '2014-04-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of Subjects With Average Serum Potassium Values ≤ 5.1 mmol/L', 'timeFrame': '11 months', 'description': 'The proportions of subjects with average serum potassium (S-K) values ≤ 5.1 mmol/L during Extended Dosing Study Days 8 to 337, inclusive'}], 'secondaryOutcomes': [{'measure': 'Proportion of Subjects With Average Serum Potassium Values ≤ 5.5 mmol/L', 'timeFrame': '11 months', 'description': 'The proportions of subjects with average S-K values ≤ 5.5 mmol/L during Extended Dosing Study Days 8 to 337, inclusive'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkalemia']}, 'descriptionModule': {'briefSummary': 'Subjects who completed the Double-blind Randomized Maintenance Phase (DBRMP) Study Day 29 visit in ZS-004 (NCT 02088073) and have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive or who discontinued during ZS-004 due to hypo- or hyperkalemia in the DBRMP and have a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive may have the option to participate in ZS-004E (NCT 021070920). Subjects who discontinued from study ZS-004 due to any other reasons (e.g. adverse events, poor compliance, investigator decision) will not be entered into study ZS-004E. All subjects who continue into the extension study must begin dosing within two (2) days after the last dose of investigational product in ZS-004.', 'detailedDescription': "All subjects with i-STAT potassium values between 3.5-5.5 mmol/l, inclusive at the ZS-004 (NCT 02088073) DBRMP Study Day 29 visit, who continue directly into the open-label extension study ZS-004E (NCT 021070920), will enter the Maintenance Phase (MP) and start on open-label ZS at a dose of 10g qd. All subjects with i-STAT potassium values \\> 5.5 mmol/l at the ZS-004 DBRMP Study Day 29 visit will undergo an acute treatment phase (AP) where they will receive ZS 10g three times a day (tid) for 24 (3 doses) or 48 hours (6 doses). If the subject's i-STAT potassium is between 3.5-5.0 mmol/l, inclusive after 24 (AP Study Day 2) or 48 hours (AP Study Day 3), the subject will enter the MP at a starting dose of 10g qd.\n\nFor subjects who discontinued during ZS-004 DBRMP due to hypo- or hyperkalemia baseline potassium values will be determined within 1 day of administration of the first dose in the ZS-004E extension study by taking two (2) consecutive i-STAT potassium measurements at 0 and 60 minutes (± 10 minutes). If the mean i-STAT value is between 3.5 - 5.5 mmol/l, inclusive, the subject will enter directly into the MP and receive 10g ZS qd; if the mean i-STAT potassium value is \\> 5.5 mmol/l, the subject will enter the AP. If i-STAT potassium values are still \\>5.0 mmol/l on the morning of AP Study Day 3, subjects will not enter the MP but will be referred to their normal health care provider for standard of care.\n\nIf the i-STAT potassium value increases above 5.5 mmol/l during the MP with treatment at 10g qd, the dose can be increased to15g qd. Conversely, if S-K decreases to between 3.0-3.4 mmol/l, inclusive, the dose of ZS can be decreased in 5g qd, decrements. If a subject is on a 5g qd dose and still develops blood potassium i-STAT values between 3.0 - 3.4mmol, inclusive the dose can be reduced to 5g every other day.\n\nSubjects will receive up to 11 months of treatment with open-label ZS."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of written informed consent.\n* Completed the ZS-004 DBRMP Study Day 29 visit or discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia and able to start dosing in ZS-004E within two (2) days after the last dose of Investigational product in ZS-004.\n* Subject must have an i-STAT potassium value that is 3.5 to 6.2 mmol/l inclusive at the ZS-004 DBRMP Study Day 29 visit or a mean i-STAT potassium value from two consecutive measurements at 0 and 60 minutes on Acute Phase Day 1/Maintenance Phase Day 1 that is 3.5 to 6.2 mmol/l inclusive if the subject discontinued study ZS-004 during the DBRMP due to hypo- or hyperkalemia .\n\nExclusion Criteria:\n\n* Pseudohyperkalemia signs and symptoms, such as excessive fist clenching hemolyzed blood specimen, history of severe leukocytosis or thrombocytosis.\n* Subjects who received alternative treatment for hyperkalemia while participating in study ZS-004.\n* Subjects with a life expectancy of less than 3 months.\n* Subjects who are severely physically or mentally incapacitated and who in the opinion of investigator are unable to perform the subjects' tasks associated with the protocol.\n* Women who are pregnant, lactating, or planning to become pregnant.\n* Subjects with diabetic ketoacidosis.\n* Presence of any condition which, in the opinion of the investigator, places the subject at undue risk or potentially jeopardizes the quality of the data to be generated.\n* Known hypersensitivity or previous anaphylaxis to ZS or to components thereof.\n* Treatment with a drug or device other than ZS within the last 30 days that has not received regulatory approval at the time of study entry.\n* Subjects with cardiac arrhythmias that require immediate treatment.\n* Subjects on dialysis."}, 'identificationModule': {'nctId': 'NCT02107092', 'briefTitle': 'Open-label Safety & Efficacy of ZS (Sodium Zirconium Cyclosilicate)10g qd to Extend Study ZS-004 in Hyperkalemia.', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZS Pharma, Inc.'}, 'officialTitle': 'Open-label Extension to Study ZS-004 [Phase 3 Multicenter, Multi-phase, Multi-dose, Prospective, Randomized, Double-blind, Placebo-controlled Maintenance Study of Safety Efficacy of ZS (Sodium Zirconium Cycolsilicate) in Hyperkalemia.]', 'orgStudyIdInfo': {'id': 'ZS-004E'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Zirconium Cyclosilicate', 'description': 'Open label oral administration of sodium zirconium cyclosilicate 10g once daily for 11 months.', 'interventionNames': ['Drug: Sodium Zirconium Cyclosilicate']}], 'interventions': [{'name': 'Sodium Zirconium Cyclosilicate', 'type': 'DRUG', 'otherNames': ['ZS'], 'description': 'Oral 10g once daily with breakfast for 11 months.', 'armGroupLabels': ['Sodium Zirconium Cyclosilicate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '35768', 'city': 'Scottsboro', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.67231, 'lon': -86.03415}}, {'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '90716', 'city': 'Hawaiian Gardens', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.8314, 'lon': -118.07284}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90723', 'city': 'Paramount', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.88946, 'lon': -118.15979}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '33462', 'city': 'Atlantis', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.5909, 'lon': -80.10088}}, {'zip': '34208', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '34601', 'city': 'Brooksville', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.55554, 'lon': -82.38991}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'zip': '33015', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33125', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '33018', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32168', 'city': 'New Smyrna Beach', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.02582, 'lon': -80.927}}, {'zip': '34471', 'city': 'Ocala', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '34491', 'city': 'Summerfield', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 29.00859, 'lon': -82.03481}}, {'zip': '33607', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33614', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '31901', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '30030', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '60805', 'city': 'Evergreen Park', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.72059, 'lon': -87.70172}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '71101', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '04210', 'city': 'Auburn', 'state': 'Maine', 'country': 'United States', 'geoPoint': {'lat': 44.09785, 'lon': -70.23117}}, {'zip': '48047', 'city': 'Chesterfield', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.66281, 'lon': -82.84242}}, {'zip': '64411', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89115', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11355', 'city': 'Flushing', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 40.76538, 'lon': -73.81736}}, {'zip': '16602', 'city': 'Altoona', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.51868, 'lon': -78.39474}}, {'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29118', 'city': 'Orangeburg', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.49182, 'lon': -80.85565}}, {'zip': '29150', 'city': 'Sumter', 'state': 'South Carolina', 'country': 'United States', 'geoPoint': {'lat': 33.92044, 'lon': -80.34147}}, {'zip': '37408', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Gosford', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.4244, 'lon': 151.34399}}, {'city': 'Woolloongabba', 'state': 'Queensland', 'country': 'Australia', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'city': 'Heidelberg', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.75, 'lon': 145.06667}}, {'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'city': 'Meyerspark', 'country': 'South Africa', 'geoPoint': {'lat': -25.74111, 'lon': 28.32162}}, {'city': 'Port Elizabeth', 'country': 'South Africa', 'geoPoint': {'lat': -33.96109, 'lon': 25.61494}}, {'city': 'Somerset West', 'country': 'South Africa', 'geoPoint': {'lat': -34.08401, 'lon': 18.82113}}], 'overallOfficials': [{'name': 'Henrik Rasmussen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'ZS Pharma, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZS Pharma, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}