Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2026-04-15 @ 9:04 AM
Study NCT ID:
NCT02081534
Status:
COMPLETED
Last Update Posted:
2020-09-14
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dose Finding Study to Treat High Phosphate Levels in the Blood.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000599417', 'term': 'tenapanor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'drosenbaum@ardelyx.com', 'phone': '6175134929', 'title': 'Chief Development Officer', 'organization': 'Ardelyx'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for a total of 5 weeks; 4-weeks of treatment and 1 treatment-free week', 'eventGroups': [{'id': 'EG000', 'title': '1 mg Bid', 'description': '1 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 6, 'seriousNumAtRisk': 23, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '3 mg Bid', 'description': '3 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 6, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '10 mg Bid', 'description': '10 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 11, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': '30 mg Bid', 'description': '30 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 17, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': '3 mg od', 'description': '3 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG005', 'title': '30 mg od', 'description': '30 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 11, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': 'Placebo (double dummy technique)\n\nPlacebo: Placebo bid, double dummy technique', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 3, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Head injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Rectal prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Phosphate Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}, {'value': '21', 'groupId': 'OG005'}, {'value': '26', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg Bid', 'description': '1 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG001', 'title': '3 mg Bid', 'description': '3 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG002', 'title': '10 mg Bid', 'description': '10 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG003', 'title': '30 mg Bid', 'description': '30 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG004', 'title': '3 mg od', 'description': '3 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG005', 'title': '30 mg od', 'description': '30 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG006', 'title': 'Placebo', 'description': 'Placebo (double dummy technique)\n\nPlacebo: Placebo bid, double dummy technique'}], 'classes': [{'categories': [{'measurements': [{'value': '-.47', 'spread': '1.553', 'groupId': 'OG000'}, {'value': '-1.18', 'spread': '1.391', 'groupId': 'OG001'}, {'value': '-1.7', 'spread': '2.018', 'groupId': 'OG002'}, {'value': '-1.98', 'spread': '2.007', 'groupId': 'OG003'}, {'value': '-.56', 'spread': '1.763', 'groupId': 'OG004'}, {'value': '-1.11', 'spread': '1.469', 'groupId': 'OG005'}, {'value': '-.54', 'spread': '1.802', 'groupId': 'OG006'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004', 'OG005', 'OG006'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'End of wash out (pre randomization value) to end of treatment (Day 29)', 'description': 'Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'two patients in the 30 mg bid group are not included in the analysis since they had no post randomization serum phosphorus measurements'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Calcium x Phosphorus Product', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}, {'value': '24', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': '1 mg Bid', 'description': '1 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG001', 'title': '3 mg Bid', 'description': '3 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG002', 'title': '10 mg Bid', 'description': '10 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG003', 'title': '30 mg Bid', 'description': '30 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG004', 'title': '3 mg od', 'description': '3 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG005', 'title': '30 mg od', 'description': '30 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'OG006', 'title': 'Placebo', 'description': 'Placebo (double dummy technique)\n\nPlacebo: Placebo bid, double dummy technique'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.16', 'spread': '9.75', 'groupId': 'OG000'}, {'value': '-12.02', 'spread': '14.02', 'groupId': 'OG001'}, {'value': '-12.44', 'spread': '15.94', 'groupId': 'OG002'}, {'value': '-16.6', 'spread': '18.01', 'groupId': 'OG003'}, {'value': '-3.59', 'spread': '18.59', 'groupId': 'OG004'}, {'value': '-11.02', 'spread': '11.57', 'groupId': 'OG005'}, {'value': '-2.50', 'spread': '13.67', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'End of wash out (pre randomization value) to end of treatment (Day 29)', 'description': 'Change from baseline (end of wash out) in calcium x phosphorus product', 'unitOfMeasure': 'mg/dL * mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The number of patients analyzed are less than the randomized number since the data to accomplish the analysis was not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1 mg Bid', 'description': '1 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG001', 'title': '3 mg Bid', 'description': '3 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG002', 'title': '10 mg Bid', 'description': '10 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG003', 'title': '30 mg Bid', 'description': '30 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG004', 'title': '3 mg od', 'description': '3 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG005', 'title': '30 mg od', 'description': '30 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'FG006', 'title': 'Placebo', 'description': 'Placebo (double dummy technique)\n\nPlacebo: Placebo bid, double dummy technique'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '26'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '21'}, {'groupId': 'FG006', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '18'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '13'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '8'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}, {'value': '21', 'groupId': 'BG005'}, {'value': '26', 'groupId': 'BG006'}, {'value': '162', 'groupId': 'BG007'}]}], 'groups': [{'id': 'BG000', 'title': '1 mg Bid', 'description': '1 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG001', 'title': '3 mg Bid', 'description': '3 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG002', 'title': '10 mg Bid', 'description': '10 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG003', 'title': '30 mg Bid', 'description': '30 mg AZD1722 bid\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG004', 'title': '3 mg od', 'description': '3 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG005', 'title': '30 mg od', 'description': '30 mg AZD1722 od\n\nAZD1722: tenapanor, oral tablet'}, {'id': 'BG006', 'title': 'Placebo', 'description': 'Placebo (double dummy technique)\n\nPlacebo: Placebo bid, double dummy technique'}, {'id': 'BG007', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.9', 'spread': '14.79', 'groupId': 'BG000'}, {'value': '61.5', 'spread': '11.21', 'groupId': 'BG001'}, {'value': '62.7', 'spread': '12.53', 'groupId': 'BG002'}, {'value': '59.7', 'spread': '12.96', 'groupId': 'BG003'}, {'value': '57.6', 'spread': '15.78', 'groupId': 'BG004'}, {'value': '58.2', 'spread': '15.75', 'groupId': 'BG005'}, {'value': '56.1', 'spread': '13.14', 'groupId': 'BG006'}, {'value': '59.1', 'spread': '14.1', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '12', 'groupId': 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'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '20', 'groupId': 'BG006'}, {'value': '114', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '8', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '9', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}, {'value': '35', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}, {'value': '106', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'serum phosphorus', 'classes': [{'categories': [{'measurements': [{'value': '7.55', 'spread': '1.003', 'groupId': 'BG000'}, {'value': '7.92', 'spread': '1.005', 'groupId': 'BG001'}, {'value': '7.32', 'spread': '1.063', 'groupId': 'BG002'}, {'value': '7.76', 'spread': '1.183', 'groupId': 'BG003'}, {'value': '7.73', 'spread': '1.276', 'groupId': 'BG004'}, {'value': '7.61', 'spread': '0.847', 'groupId': 'BG005'}, {'value': '7.87', 'spread': '1.488', 'groupId': 'BG006'}, {'value': '7.68', 'spread': '1.124', 'groupId': 'BG007'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 162}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-25', 'studyFirstSubmitDate': '2014-03-06', 'resultsFirstSubmitDate': '2020-08-06', 'studyFirstSubmitQcDate': '2014-03-06', 'lastUpdatePostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-25', 'studyFirstPostDateStruct': {'date': '2014-03-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Serum Phosphate Levels', 'timeFrame': 'End of wash out (pre randomization value) to end of treatment (Day 29)', 'description': 'Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Calcium x Phosphorus Product', 'timeFrame': 'End of wash out (pre randomization value) to end of treatment (Day 29)', 'description': 'Change from baseline (end of wash out) in calcium x phosphorus product'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['S-phosphate, hyperphosphatemia, hemodialysis, ESRD'], 'conditions': ['Hyperphosphatemia']}, 'referencesModule': {'references': [{'pmid': '38323855', 'type': 'DERIVED', 'citation': 'Sprague SM, Weiner DE, Tietjen DP, Pergola PE, Fishbane S, Block GA, Silva AL, Fadem SZ, Lynn RI, Fadda G, Pagliaro L, Zhao S, Edelstein S, Spiegel DM, Rosenbaum DP. Tenapanor as Therapy for Hyperphosphatemia in Maintenance Dialysis Patients: Results from the OPTIMIZE Study. Kidney360. 2024 May 1;5(5):732-742. doi: 10.34067/KID.0000000000000387. Epub 2024 Feb 7.'}, {'pmid': '29617976', 'type': 'DERIVED', 'citation': 'Block GA, Rosenbaum DP, Yan A, Greasley PJ, Chertow GM, Wolf M. The effects of tenapanor on serum fibroblast growth factor 23 in patients receiving hemodialysis with hyperphosphatemia. Nephrol Dial Transplant. 2019 Feb 1;34(2):339-346. doi: 10.1093/ndt/gfy061.'}]}, 'descriptionModule': {'briefSummary': 'Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period', 'detailedDescription': 'The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.\n\nThe wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.\n\nThere are 7 parallel treatment arms in the study with bid and od treatment regimens.\n\nLaboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.\n\nThe target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females and males aged ≥18 years\n2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months\n3. Prescribed and taking at least 3 doses of phosphate binder per day\n4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening\n5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening\n6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out\n\nExclusion Criteria:\n\n1. Severe hyperphosphatemia defined as \\>10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.\n2. Serum parathyroid hormone \\>1200 pg/mL\n3. Significant metabolic acidosis\n4. Clinical signs of hypovolemia at randomization\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02081534', 'briefTitle': 'Dose Finding Study to Treat High Phosphate Levels in the Blood.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardelyx'}, 'officialTitle': 'A Phase 2b, Randomized, Double Blind, Placebo-controlled, Parallel Group, Multicentre Dose Finding Study to Evaluate the Efficacy, Safety and Tolerability of AZD1722 to Treat Hyperphosphatemia in End-Stage Renal Disease Patients on Hemodialysis (ESRD-HD)', 'orgStudyIdInfo': {'id': 'D5613C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 mg bid', 'description': '1 mg AZD1722 bid', 'interventionNames': ['Drug: AZD1722']}, {'type': 'EXPERIMENTAL', 'label': '3 mg bid', 'description': '3 mg AZD1722 bid', 'interventionNames': ['Drug: AZD1722']}, {'type': 'EXPERIMENTAL', 'label': '10 mg bid', 'description': '10 mg AZD1722 bid', 'interventionNames': ['Drug: AZD1722']}, {'type': 'EXPERIMENTAL', 'label': '30 mg bid', 'description': '30 mg AZD1722 bid', 'interventionNames': ['Drug: AZD1722']}, {'type': 'EXPERIMENTAL', 'label': '3 mg od', 'description': '3 mg AZD1722 od', 'interventionNames': ['Drug: AZD1722']}, {'type': 'EXPERIMENTAL', 'label': '30 mg od', 'description': '30 mg AZD1722 od', 'interventionNames': ['Drug: AZD1722']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (double dummy technique)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AZD1722', 'type': 'DRUG', 'description': 'AZD1722, oral tablet', 'armGroupLabels': ['1 mg bid', '10 mg bid', '3 mg bid', '3 mg od', '30 mg bid', '30 mg od']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo bid, double dummy technique', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Downey', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.94001, 'lon': 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'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 'Leicester', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 52.6386, 'lon': -1.13169}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Geoffrey A Block, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Denver Nephrology PC, Denver, CO 80230'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardelyx', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}