Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-20 @ 6:42 PM
Study NCT ID:
NCT02875834
Status:
COMPLETED
Last Update Posted:
2020-08-19
First Post:
2016-07-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Investigate the Safety and Efficacy of ZS in Patients With 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', 'organization': 'AstraZeneca'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Through 28-day randomized treatment study phase day 8-29', 'eventGroups': [{'id': 'EG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.', 'otherNumAtRisk': 267, 'deathsNumAtRisk': 267, 'otherNumAffected': 0, 'seriousNumAtRisk': 267, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 6, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.', 'otherNumAtRisk': 99, 'deathsNumAtRisk': 99, 'otherNumAffected': 21, 'seriousNumAtRisk': 99, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Oedema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Infectious colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 267, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 99, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 50, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Least Square Mean S-K Level on Days 8-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.811', 'groupId': 'OG001', 'lowerLimit': '4.685', 'upperLimit': '4.940'}, {'value': '4.381', 'groupId': 'OG002', 'lowerLimit': '4.265', 'upperLimit': '4.501'}, {'value': '5.321', 'groupId': 'OG003', 'lowerLimit': '5.155', 'upperLimit': '5.493'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.904', 'ciLowerLimit': '0.876', 'ciUpperLimit': '0.933', 'groupDescription': 'Results derived from a mixed effects model of log-transformed S-K levels. Fixed effects are: treatment group; visit; treatment-by-visit interaction; baseline S-K values (OLP and RTP); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses. Patient is a random effect. p-values given are for differences of LSMEANS. The back-transformation is to the original scale of the S-K measurement.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.823', 'ciLowerLimit': '0.797', 'ciUpperLimit': '0.850', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through 28-day randomized treatment study phase day 8-29.', 'description': 'Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29. The results in the table below are presented for RTP.', 'unitOfMeasure': 'mmol/L', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Achieving Normokalemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'Normokalemic at 24h', 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}]}]}, {'title': 'Not Normokalemic at 24h', 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG000'}]}]}, {'title': 'Missing at 24h', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Normokalemic at 48h', 'categories': [{'measurements': [{'value': '238', 'groupId': 'OG000'}]}]}, {'title': 'Not Normokalemic at 48h', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Missing at 48h', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours. The results in the table below are presented for OLP. (h=hours).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Exponential Rate of Change in S-K Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0001', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase. The results in the table below are presented for OLP.', 'unitOfMeasure': 'log(mmol/L)/h', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Absolute Change From Baseline in S-K Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'OLP Day 1-1h post-first dose absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.444', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 1-2h post-first dose absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.48', 'spread': '0.452', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 1-4h post-first dose absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.57', 'spread': '0.494', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 2-24h absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.81', 'spread': '0.398', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 2-1h post-first dose absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.91', 'spread': '0.445', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 3-48h absolute change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.499', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Absolute change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Percentage Change From Baseline in S-K Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'OLP Day 1-1h post-first dose percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-3.26', 'spread': '7.949', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 1-2h post-first dose percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-8.29', 'spread': '7.792', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 1-4h post-first dose percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-9.88', 'spread': '8.494', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 2-24h percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.08', 'spread': '6.479', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 2-1h post-first dose percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '261', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.84', 'spread': '7.243', 'groupId': 'OG000'}]}]}, {'title': 'OLP Day 3-48h percentage change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '260', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.16', 'spread': '7.812', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Percentage change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Patients Remaining Normokalemic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.3436', 'ciLowerLimit': '2.6866', 'ciUpperLimit': '14.9782', 'groupDescription': 'Treatment group comparisons were made using a logistic regression model containing the following covariates: treatment group; both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase); baseline eGFR (during 48-hour open-label initial phase); age category (\\<55, 55-64, \\>=65 years); country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.1876', 'ciLowerLimit': '7.1591', 'ciUpperLimit': '46.2054', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Through 28-day randomized treatment study phase day 8-29.', 'description': 'The proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '93', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}]}]}, {'title': 'Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '89', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}]}, {'title': 'Day 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}]}]}, {'title': 'Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Day 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Day 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG001'}, {'value': '76', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Day 22', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG001'}, {'value': '73', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Day 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '51', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}]}, {'title': 'Day 29/Exit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '58', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The proportion of patients who are normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at Day 1 through Day 29/Exit in randomization phase. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Days Patients Remain Normokalemic', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.810', 'spread': '1.113', 'groupId': 'OG001'}, {'value': '15.623', 'spread': '1.143', 'groupId': 'OG002'}, {'value': '3.543', 'spread': '1.351', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '7.266', 'ciLowerLimit': '4.318', 'ciUpperLimit': '10.214', 'groupDescription': 'Results derived from a linear regression model with the following covariates: treatment group; baseline S-K values (Open-label phase and Randomized treatment phase); baseline eGFR; age category; country; baseline RAAS inhibitor, chronic kidney disease, heart failure, and diabetes mellitus statuses.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.079', 'ciLowerLimit': '9.118', 'ciUpperLimit': '15.040', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The number of days patients remain normokalemic during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mean Change in S-K Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'Day 2 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.354', 'groupId': 'OG001'}, {'value': '-0.09', 'spread': '0.372', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.443', 'groupId': 'OG003'}]}]}, {'title': 'Day 5 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.23', 'spread': '0.478', 'groupId': 'OG001'}, {'value': '-0.08', 'spread': '0.439', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '0.562', 'groupId': 'OG003'}]}]}, {'title': 'Day 8 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.44', 'spread': '0.487', 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.489', 'groupId': 'OG002'}, {'value': '0.91', 'spread': '0.622', 'groupId': 'OG003'}]}]}, {'title': 'Day 12 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.53', 'spread': '0.560', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.573', 'groupId': 'OG002'}, {'value': '0.97', 'spread': '0.646', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.54', 'spread': '0.584', 'groupId': 'OG001'}, {'value': '0.04', 'spread': '0.564', 'groupId': 'OG002'}, {'value': '0.85', 'spread': '0.585', 'groupId': 'OG003'}]}]}, {'title': 'Day 19 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.56', 'spread': '0.578', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.576', 'groupId': 'OG002'}, {'value': '0.97', 'spread': '0.566', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.555', 'groupId': 'OG001'}, {'value': '0.10', 'spread': '0.613', 'groupId': 'OG002'}, {'value': '0.93', 'spread': '0.702', 'groupId': 'OG003'}]}]}, {'title': 'Day 26 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.51', 'spread': '0.581', 'groupId': 'OG001'}, {'value': '0.05', 'spread': '0.639', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '0.607', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.586', 'groupId': 'OG001'}, {'value': '0.02', 'spread': '0.665', 'groupId': 'OG002'}, {'value': '1.02', 'spread': '0.594', 'groupId': 'OG003'}]}]}, {'title': 'EOS change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.92', 'spread': '0.661', 'groupId': 'OG001'}, {'value': '0.77', 'spread': '0.695', 'groupId': 'OG002'}, {'value': '0.88', 'spread': '0.684', 'groupId': 'OG003'}]}]}, {'title': 'Day 2 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.28', 'spread': '0.544', 'groupId': 'OG001'}, {'value': '-1.36', 'spread': '0.515', 'groupId': 'OG002'}, {'value': '-1.07', 'spread': '0.602', 'groupId': 'OG003'}]}]}, {'title': 'Day 5 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.08', 'spread': '0.552', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '0.601', 'groupId': 'OG002'}, {'value': '-0.64', 'spread': '0.594', 'groupId': 'OG003'}]}]}, {'title': 'Day 8 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.87', 'spread': '0.578', 'groupId': 'OG001'}, {'value': '-1.28', 'spread': '0.634', 'groupId': 'OG002'}, {'value': '-0.34', 'spread': '0.661', 'groupId': 'OG003'}]}]}, {'title': 'Day 12 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.603', 'groupId': 'OG001'}, {'value': '-1.21', 'spread': '0.671', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '0.602', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.77', 'spread': '0.604', 'groupId': 'OG001'}, {'value': '-1.23', 'spread': '0.643', 'groupId': 'OG002'}, {'value': '-0.40', 'spread': '0.550', 'groupId': 'OG003'}]}]}, {'title': 'Day 19 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.74', 'spread': '0.639', 'groupId': 'OG001'}, {'value': '-1.20', 'spread': '0.672', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '0.533', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.84', 'spread': '0.597', 'groupId': 'OG001'}, {'value': '-1.15', 'spread': '0.730', 'groupId': 'OG002'}, {'value': '-0.38', 'spread': '0.571', 'groupId': 'OG003'}]}]}, {'title': 'Day 26 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.79', 'spread': '0.687', 'groupId': 'OG001'}, {'value': '-1.21', 'spread': '0.762', 'groupId': 'OG002'}, {'value': '-0.28', 'spread': '0.563', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.82', 'spread': '0.604', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '0.734', 'groupId': 'OG002'}, {'value': '-0.27', 'spread': '0.515', 'groupId': 'OG003'}]}]}, {'title': 'EOS change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '0.649', 'groupId': 'OG001'}, {'value': '-0.50', 'spread': '0.725', 'groupId': 'OG002'}, {'value': '-0.36', 'spread': '0.702', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mean Percentage Change in S-K Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'Day 2 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.00', 'spread': '8.459', 'groupId': 'OG001'}, {'value': '-1.74', 'spread': '7.981', 'groupId': 'OG002'}, {'value': '4.19', 'spread': '10.592', 'groupId': 'OG003'}]}]}, {'title': 'Day 5 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.51', 'spread': '11.337', 'groupId': 'OG001'}, {'value': '-1.52', 'spread': '9.691', 'groupId': 'OG002'}, {'value': '14.19', 'spread': '13.162', 'groupId': 'OG003'}]}]}, {'title': 'Day 8 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.26', 'spread': '11.340', 'groupId': 'OG001'}, {'value': '0.16', 'spread': '11.062', 'groupId': 'OG002'}, {'value': '21.55', 'spread': '15.634', 'groupId': 'OG003'}]}]}, {'title': 'Day 12 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.41', 'spread': '13.113', 'groupId': 'OG001'}, {'value': '1.60', 'spread': '13.205', 'groupId': 'OG002'}, {'value': '22.87', 'spread': '16.457', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.50', 'spread': '13.378', 'groupId': 'OG001'}, {'value': '1.27', 'spread': '12.937', 'groupId': 'OG002'}, {'value': '20.15', 'spread': '14.647', 'groupId': 'OG003'}]}]}, {'title': 'Day 19 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.12', 'spread': '13.180', 'groupId': 'OG001'}, {'value': '1.70', 'spread': '13.139', 'groupId': 'OG002'}, {'value': '22.77', 'spread': '14.583', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.04', 'spread': '12.993', 'groupId': 'OG001'}, {'value': '2.66', 'spread': '14.042', 'groupId': 'OG002'}, {'value': '22.28', 'spread': '18.131', 'groupId': 'OG003'}]}]}, {'title': 'Day 26 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.02', 'spread': '13.616', 'groupId': 'OG001'}, {'value': '1.49', 'spread': '14.441', 'groupId': 'OG002'}, {'value': '23.63', 'spread': '15.353', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11.34', 'spread': '13.821', 'groupId': 'OG001'}, {'value': '0.87', 'spread': '15.084', 'groupId': 'OG002'}, {'value': '23.99', 'spread': '15.329', 'groupId': 'OG003'}]}]}, {'title': 'EOS percentage change from RTP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '21.62', 'spread': '16.027', 'groupId': 'OG001'}, {'value': '17.76', 'spread': '16.266', 'groupId': 'OG002'}, {'value': '20.70', 'spread': '17.035', 'groupId': 'OG003'}]}]}, {'title': 'Day 2 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-22.12', 'spread': '8.679', 'groupId': 'OG001'}, {'value': '-23.55', 'spread': '7.652', 'groupId': 'OG002'}, {'value': '-18.51', 'spread': '9.751', 'groupId': 'OG003'}]}]}, {'title': 'Day 5 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-18.77', 'spread': '9.347', 'groupId': 'OG001'}, {'value': '-23.31', 'spread': '9.230', 'groupId': 'OG002'}, {'value': '-10.96', 'spread': '9.724', 'groupId': 'OG003'}]}]}, {'title': 'Day 8 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}, {'value': '98', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-15.01', 'spread': '9.627', 'groupId': 'OG001'}, {'value': '-22.01', 'spread': '10.037', 'groupId': 'OG002'}, {'value': '-5.41', 'spread': '11.424', 'groupId': 'OG003'}]}]}, {'title': 'Day 12 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.55', 'spread': '9.891', 'groupId': 'OG001'}, {'value': '-20.84', 'spread': '10.981', 'groupId': 'OG002'}, {'value': '-4.57', 'spread': '10.335', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '93', 'groupId': 'OG002'}, {'value': '48', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.35', 'spread': '10.170', 'groupId': 'OG001'}, {'value': '-21.18', 'spread': '10.351', 'groupId': 'OG002'}, {'value': '-6.63', 'spread': '9.457', 'groupId': 'OG003'}]}]}, {'title': 'Day 19 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-12.79', 'spread': '11.339', 'groupId': 'OG001'}, {'value': '-20.67', 'spread': '10.834', 'groupId': 'OG002'}, {'value': '-4.89', 'spread': '9.279', 'groupId': 'OG003'}]}]}, {'title': 'Day 22 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '90', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.49', 'spread': '10.158', 'groupId': 'OG001'}, {'value': '-19.67', 'spread': '11.723', 'groupId': 'OG002'}, {'value': '-6.43', 'spread': '9.759', 'groupId': 'OG003'}]}]}, {'title': 'Day 26 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-13.35', 'spread': '11.599', 'groupId': 'OG001'}, {'value': '-20.75', 'spread': '12.360', 'groupId': 'OG002'}, {'value': '-4.74', 'spread': '9.551', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-14.09', 'spread': '9.949', 'groupId': 'OG001'}, {'value': '-21.42', 'spread': '11.659', 'groupId': 'OG002'}, {'value': '-4.61', 'spread': '8.802', 'groupId': 'OG003'}]}]}, {'title': 'EOS percentage change from OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '11.199', 'groupId': 'OG001'}, {'value': '-8.54', 'spread': '12.405', 'groupId': 'OG002'}, {'value': '-5.95', 'spread': '11.927', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean percentage change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Number of Hyperkalemic Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.443', 'ciLowerLimit': '0.2954', 'ciUpperLimit': '0.6631', 'groupDescription': 'Results derived from a Cox Proportional Hazards model with the following covariates: treatment group, both baseline S-K values (48-hours open-label initial phase and double-blind randomized phase), baseline eGFR, age category (\\<55, 55-64, \\>=65 years), country, baseline RAAS inhibitor, chronic kidney, disease heart failure, and diabetes mellitus statuses.', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}, {'pValue': '<0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.158', 'ciLowerLimit': '0.0992', 'ciUpperLimit': '0.2508', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'OTHER'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The results represent number of hyperkalemic patients during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Mean Changes in S-Aldosterone and P Renin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'Day 1 S-Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '83', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-112.69', 'spread': '178.358', 'groupId': 'OG001'}, {'value': '-85.63', 'spread': '118.017', 'groupId': 'OG002'}, {'value': '-98.54', 'spread': '168.657', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 S-Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '82', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}, {'value': '46', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-91.75', 'spread': '179.791', 'groupId': 'OG001'}, {'value': '-96.37', 'spread': '108.002', 'groupId': 'OG002'}, {'value': '39.78', 'spread': '152.050', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 S-Aldosterone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '76', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '40', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-102.70', 'spread': '212.187', 'groupId': 'OG001'}, {'value': '-90.22', 'spread': '91.149', 'groupId': 'OG002'}, {'value': '41.07', 'spread': '198.266', 'groupId': 'OG003'}]}]}, {'title': 'Day 1 P-Renin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '92', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.23', 'spread': '1.158', 'groupId': 'OG001'}, {'value': '-0.26', 'spread': '1.913', 'groupId': 'OG002'}, {'value': '-0.30', 'spread': '1.031', 'groupId': 'OG003'}]}]}, {'title': 'Day 15 P-Renin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '81', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.39', 'spread': '1.350', 'groupId': 'OG001'}, {'value': '-1.09', 'spread': '4.732', 'groupId': 'OG002'}, {'value': '0.60', 'spread': '3.250', 'groupId': 'OG003'}]}]}, {'title': 'Day 29 P-Renin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '78', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-0.27', 'spread': '1.008', 'groupId': 'OG001'}, {'value': '-1.56', 'spread': '4.165', 'groupId': 'OG002'}, {'value': '-0.25', 'spread': '2.725', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean changes from OLP baseline in S-Aldosterone and P-Renin levels. The results in the table below are presented for RTP.', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}, {'type': 'SECONDARY', 'title': 'Patient Reported Health State (EQ-5D) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '99', 'groupId': 'OG001'}, {'value': '99', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'OG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'classes': [{'title': 'OLP baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '43', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '16.44', 'groupId': 'OG001'}, {'value': '74.3', 'spread': '17.44', 'groupId': 'OG002'}, {'value': '72.7', 'spread': '17.32', 'groupId': 'OG003'}]}]}, {'title': 'Day 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '88', 'groupId': 'OG002'}, {'value': '41', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '77.6', 'spread': '16.50', 'groupId': 'OG001'}, {'value': '76.9', 'spread': '16.08', 'groupId': 'OG002'}, {'value': '76.6', 'spread': '14.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Through study completion, an average of 37 days.', 'description': 'Evaluate health state of patients using EQ-5D questionnaire. This scale is numbered from 0 to 100. 0 means the worst health you can imagine. 100 means the best health you can imagine. The results in the table below are presented for RTP.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'FG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'FG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}], 'periods': [{'title': 'Open-label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '267'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '260'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '(Not collected)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Randomized Treatment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'No subjects were randomized in 10g TID group in RTP.', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '99 subjects were randomized in 5g QD group in RTP.', 'groupId': 'FG001', 'numSubjects': '99'}, {'comment': '99 subjects were randomized in 10g QD group in RTP.', 'groupId': 'FG002', 'numSubjects': '99'}, {'comment': '50 subjects were randomized in placebo group in RTP.', 'groupId': 'FG003', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '88'}, {'groupId': 'FG003', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '11'}, {'groupId': 'FG003', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': '(Not collected)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '9'}]}]}], 'recruitmentDetails': 'This study was conducted in 42 centers within Japan, Russia, South Korea, and Taiwan.', 'preAssignmentDetails': 'the study consisted of two phases: an open-label phase (single arm, 48 hours, ZS 10 g TID; OLP) and a randomized treatment phase (3 arms, 28 days; RTP). 267 patients entered OLP. Out of these, 248 endered RTP and were randomized to placebo, ZS 5 g QD or ZS 10 g QD in a 1:2:2 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '267', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '99', 'groupId': 'BG002'}, {'value': '50', 'groupId': 'BG003'}, {'value': '515', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g Tid', 'description': 'Suspension administered 10g orally 3 times per day for the first 48-hour open label initial phase.'}, {'id': 'BG001', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'BG002', 'title': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.8', 'spread': '10.80', 'groupId': 'BG000'}, {'value': '66.7', 'spread': '11.40', 'groupId': 'BG001'}, {'value': '68.0', 'spread': '10.18', 'groupId': 'BG002'}, {'value': '69.4', 'spread': '10.26', 'groupId': 'BG003'}, {'value': '67.7', 'spread': '10.70', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'All subjects in RTP took part in OLP. Thus, the Totals are calculated using replicated measurements.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'RTP: For the 28-day randomized treatment study phase, the Full Analysis Set (FAS) will include all patients who are randomized to the 28-day randomized treatment study phase.'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '96', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '184', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}, {'value': '331', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects in RTP took part in OLP. Thus, the Totals are calculated using replicated measurements.', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '265', 'groupId': 'BG000'}, {'value': '99', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}, {'value': '511', 'groupId': 'BG004'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects in RTP took part in OLP. Thus, the Totals are calculated using replicated measurements.', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '227', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}, {'value': '443', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects in RTP took part in OLP. Thus, the Totals are calculated using replicated measurements.', 'unitOfMeasure': 'Participants'}, {'title': 'Country', 'classes': [{'categories': [{'title': 'Japan', 'measurements': [{'value': '68', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '134', 'groupId': 'BG004'}]}, {'title': 'Korea', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '235', 'groupId': 'BG004'}]}, {'title': 'Russia', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '72', 'groupId': 'BG004'}]}, {'title': 'Taiwan', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '74', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'All subjects in RTP took part in OLP. Thus, the Totals are calculated using replicated measurements.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'In RTP there were no subjects analyzed in Sodium Zirconium Cyclosilicate (ZS) 10g tid arm. In OLP, only ZS 10 g TID arm was present. All subjects in RTP took part in OLP.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-15', 'size': 1474950, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-02-11T04:42', 'hasProtocol': False}, {'date': '2017-09-22', 'size': 1025488, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-08-06T07:30', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 267}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-06', 'studyFirstSubmitDate': '2016-07-22', 'resultsFirstSubmitDate': '2019-02-12', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-06', 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Least Square Mean S-K Level on Days 8-29', 'timeFrame': 'Through 28-day randomized treatment study phase day 8-29.', 'description': 'Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29. The results in the table below are presented for RTP.'}], 'secondaryOutcomes': [{'measure': 'Proportion of Patients Achieving Normokalemia', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours. The results in the table below are presented for OLP. (h=hours).'}, {'measure': 'Exponential Rate of Change in S-K Levels', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase. The results in the table below are presented for OLP.'}, {'measure': 'Absolute Change From Baseline in S-K Levels', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Absolute change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.'}, {'measure': 'Percentage Change From Baseline in S-K Levels', 'timeFrame': 'Through 48-hour initial phase.', 'description': 'Percentage change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP.'}, {'measure': 'Proportion of Patients Remaining Normokalemic', 'timeFrame': 'Through 28-day randomized treatment study phase day 8-29.', 'description': 'The proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.'}, {'measure': 'Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The proportion of patients who are normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at Day 1 through Day 29/Exit in randomization phase. The results in the table below are presented for RTP.'}, {'measure': 'Days Patients Remain Normokalemic', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The number of days patients remain normokalemic during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.'}, {'measure': 'Mean Change in S-K Levels', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.'}, {'measure': 'Mean Percentage Change in S-K Levels', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean percentage change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP.'}, {'measure': 'Number of Hyperkalemic Patients', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The results represent number of hyperkalemic patients during the 28-day randomized treatment study phase. The results in the table below are presented for RTP.'}, {'measure': 'Mean Changes in S-Aldosterone and P Renin Levels', 'timeFrame': 'Through 28-day randomized treatment phase.', 'description': 'The mean changes from OLP baseline in S-Aldosterone and P-Renin levels. The results in the table below are presented for RTP.'}, {'measure': 'Patient Reported Health State (EQ-5D) Questionnaire', 'timeFrame': 'Through study completion, an average of 37 days.', 'description': 'Evaluate health state of patients using EQ-5D questionnaire. This scale is numbered from 0 to 100. 0 means the worst health you can imagine. 100 means the best health you can imagine. The results in the table below are presented for RTP.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperkalemia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4401&filename=d9480c00002-sap-ed-2_Redacted_CTT.PDF', 'label': 'Related Info'}, {'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4401&filename=d9480c00002-csp-v3_Redacted_CTT.PDF', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of two different doses (5 and 10 g) of ZS orally administered once daily (qd) vs placebo in maintaining normokalemia in initially hyperkalemic patients having achieved normokalemia following two days of initial ZS therapy (10g TID).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures\n* Female and male patients aged ≥18 and ≤ 90 years\n* Two consecutive i-STAT potassium values, measured 60-minutes (± 10 minutes) apart, both ≥ 5.1 mmol/l and measured within 1 day of the first ZS dose on 48-hour open-label initial phase Day 1\n* Ability to have repeated blood draws or effective venous catheterization\n* Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception for the duration of the study and for 3 months after the last dose of ZS/matching placebo to prevent pregnancy.\n\nExclusion Criteria:\n\n* Involvement in the planning and/or conduct of the study\n* Participation in another clinical study with an investigational product during the last 3 months\n* Pseudohyperkalemia signs and symptoms\n* Patients treated with lactulose, xifaxan (rifaximin) or other non-absorbed antibiotics for hyperammonemia within 7 days prior to the first dose of study drug\n* Patients treated with resins,calcium acetate,calcium carbonate, or lanthanum carbonate,within 7 days prior to the first dose of study drug\n* Patients with a life expectancy of less than 3 months\n* Patients 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* Female patients who are pregnant, lactating, or planning to become pregnant\n* Patients with diabetic ketoacidosis\n* Presence of any condition which, in the opinion of the investigator, places the patient 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* Patients with cardiac arrhythmias that require immediate treatment\n* Patients on dialysis\n* Patients who are blood donors should not donate blood during the study and for 3 months following their last dose of ZS"}, 'identificationModule': {'nctId': 'NCT02875834', 'acronym': 'HARMONIZE GL', 'briefTitle': 'A Study to Investigate the Safety and Efficacy of ZS in Patients With Hyperkalemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 3 Multicenter, Prospective, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety and Efficacy of ZS, in Patients With Hyperkalemia-HARMONIZE Global', 'orgStudyIdInfo': {'id': 'D9480C00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.', 'interventionNames': ['Drug: Sodium Zirconium Cyclosilicate (ZS) 5g']}, {'type': 'EXPERIMENTAL', 'label': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.', 'interventionNames': ['Drug: Sodium Zirconium Cyclosilicate (ZS) 10g']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'type': 'DRUG', 'description': 'Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)', 'armGroupLabels': ['Sodium Zirconium Cyclosilicate (ZS) 10g']}, {'name': 'Sodium Zirconium Cyclosilicate (ZS) 5g', 'type': 'DRUG', 'description': 'Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.', 'armGroupLabels': ['Sodium Zirconium Cyclosilicate (ZS) 5g']}, {'name': 'Sodium Zirconium Cyclosilicate (ZS) 10g', 'type': 'DRUG', 'description': 'Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.', 'armGroupLabels': ['Sodium Zirconium Cyclosilicate (ZS) 10g']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '260-8712', 'city': 'Chiba', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.6, 'lon': 140.11667}}, {'zip': '348-8505', 'city': 'Hanyu-shi', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '312-0057', 'city': 'Hitachi-Naka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.39659, 'lon': 140.53479}}, {'zip': '396-8555', 'city': 'Ina-shi', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '920-8650', 'city': 'Kanazawa', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 36.6, 'lon': 136.61667}}, {'zip': '306-0041', 'city': 'Koga-shi', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '271-0077', 'city': 'Matsudo-shi', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '457-8511', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '462-0802', 'city': 'Nagoya', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '901-0493', 'city': 'Shimajiri-gun', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '421-0117', 'city': 'Shizuoka', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.98333, 'lon': 138.38333}}, {'zip': '302-0022', 'city': 'Toride-shi', 'country': 'Japan', 'facility': 'Research Site'}, {'zip': '441-8570', 'city': 'Toyohashi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 34.76667, 'lon': 137.38333}}, {'zip': '581-0011', 'city': 'Yakushi', 'country': 'Japan', 'facility': 'Research Site', 'geoPoint': {'lat': 32.04135, 'lon': 130.62864}}, {'zip': '660062', 'city': 'Krasnoyarsk', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.03742, 'lon': 92.93136}}, {'zip': '123423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '194354', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '196601', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '150062', 'city': 'Yaroslavl', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 57.62987, 'lon': 39.87368}}, {'zip': '620039', 'city': 'Yekaterinburg', 'country': 'Russia', 'facility': 'Research Site', 'geoPoint': {'lat': 56.85733, 'lon': 60.61529}}, {'zip': '14068', 'city': 'Anyang-si', 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