Viewing Study NCT01521494

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Ignite Creation Date: 2025-12-25 @ 1:41 AM
Ignite Modification Date: 2026-01-26 @ 1:09 AM
Study NCT ID: NCT01521494
Status: COMPLETED
Last Update Posted: 2018-08-23
First Post: 2012-01-26
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D010760', 'term': 'Phosphorus Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rinsyousiken@pharm.kissei.co.jp', 'phone': 'Email only', 'title': 'Clinical Development Division', 'organization': 'Kissei Pharmaceutical Co., Ltd'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 13, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 11, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 19, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 20, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Placebo', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 11, 'seriousNumAtRisk': 37, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 15}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Liver abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Prostate cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 36, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 37, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21'}, {'id': 'OG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21'}, {'id': 'OG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21'}, {'id': 'OG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.84', 'groupId': 'OG000', 'lowerLimit': '-2.23', 'upperLimit': '-1.44'}, {'value': '-2.59', 'groupId': 'OG001', 'lowerLimit': '-3.01', 'upperLimit': '-2.17'}, {'value': '-3.17', 'groupId': 'OG002', 'lowerLimit': '-3.60', 'upperLimit': '-2.74'}, {'value': '-3.78', 'groupId': 'OG003', 'lowerLimit': '-4.20', 'upperLimit': '-3.36'}, {'value': '0.14', 'groupId': 'OG004', 'lowerLimit': '-0.26', 'upperLimit': '0.55'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '6 weeks', 'description': 'Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 5 patients were excluded from analysis because they failed to have primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Calcium Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '33', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21'}, {'id': 'OG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21'}, {'id': 'OG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21'}, {'id': 'OG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.20', 'spread': '0.34', 'groupId': 'OG000'}, {'value': '0.16', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '0.38', 'spread': '0.44', 'groupId': 'OG002'}, {'value': '0.38', 'spread': '0.39', 'groupId': 'OG003'}, {'value': '-0.09', 'spread': '0.31', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Total of 5 patients were excluded from analysis because they failed to have primary endpoint.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum Intact-PTH Concentrations.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21'}, {'id': 'OG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21'}, {'id': 'OG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21'}, {'id': 'OG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-35.2', 'spread': '89.8', 'groupId': 'OG000'}, {'value': '-45.6', 'spread': '79.2', 'groupId': 'OG001'}, {'value': '-97.0', 'spread': '92.7', 'groupId': 'OG002'}, {'value': '-86.5', 'spread': '104.0', 'groupId': 'OG003'}, {'value': '21.5', 'spread': '82.5', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Some patients were excluded from analysis because they failed to have primary endpoint or missed to measure intact-PTH at the end of treatment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21'}, {'id': 'FG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21'}, {'id': 'FG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21'}, {'id': 'FG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21'}, {'id': 'FG004', 'title': 'Placebo', 'description': 'Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '37'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '31'}, {'groupId': 'FG002', 'numSubjects': '23'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '21'}, {'groupId': 'FG004', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Decrease in serum phosphate', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Decrease in serum calcium', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'PA21 750 mg/Day', 'description': 'PA21'}, {'id': 'BG001', 'title': 'PA21 1500 mg/Day', 'description': 'PA21'}, {'id': 'BG002', 'title': 'PA21 2250 mg/Day', 'description': 'PA21'}, {'id': 'BG003', 'title': 'PA21 3000 mg/Day', 'description': 'PA21'}, {'id': 'BG004', 'title': 'Placebo', 'description': 'Placebo'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.4', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '63.8', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '10.5', 'groupId': 'BG002'}, {'value': '61.4', 'spread': '11.2', 'groupId': 'BG003'}, {'value': '60.8', 'spread': '10.2', 'groupId': 'BG004'}, {'value': '61.4', 'spread': '10.9', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '63', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', '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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'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'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'White', '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'}]}, {'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'}]}, {'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'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dialysis vintage', 'classes': [{'categories': [{'measurements': [{'value': '77.6', 'spread': '67.5', 'groupId': 'BG000'}, {'value': '85.1', 'spread': '60.7', 'groupId': 'BG001'}, {'value': '95.8', 'spread': '81.9', 'groupId': 'BG002'}, {'value': '91.5', 'spread': '58.6', 'groupId': 'BG003'}, {'value': '71.0', 'spread': '45.0', 'groupId': 'BG004'}, {'value': '83.7', 'spread': '63.5', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Total of 5 patients were excluded from analysis because they failed to have primary endpoint.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2012-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-27', 'studyFirstSubmitDate': '2012-01-26', 'resultsFirstSubmitDate': '2017-11-27', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-27', 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Serum Phosphorus Concentrations at the End of Treatment.', 'timeFrame': '6 weeks', 'description': 'Changes in serum phosphorus concentrations from baseline to the end of treatment were adjusted by serum phosphorus concentration at baseline.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Serum Calcium Concentrations.', 'timeFrame': '6 weeks'}, {'measure': 'Change From Baseline in Serum Intact-PTH Concentrations.', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Hyperphosphatemia'], 'conditions': ['Chronic Kidney Disease Requiring Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '40576086', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.'}]}, 'descriptionModule': {'briefSummary': 'To investigate dose-response efficacy and safety in hemodialysis patients with hyperphosphatemia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age 20 or older, regardless of gender.\n* Receiving stable maintenance hemodialysis 3 times a week.\n* Patients not having changed their phosphate binder agent dose, for 4 weeks or more before their observation period start.\n\nExclusion Criteria:\n\n* Patients having history of a pronounced brain / cardiovascular disorder.\n* Patients having severe gastrointestinal disorders.\n* Patients having severe hepatic disorders.'}, 'identificationModule': {'nctId': 'NCT01521494', 'briefTitle': 'PA21 Phase II Clinical Study in Hemodialysis Patients With Hyperphosphatemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'PA1201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA21 750 mg/day', 'interventionNames': ['Drug: PA21']}, {'type': 'EXPERIMENTAL', 'label': 'PA21 1500 mg/day', 'interventionNames': ['Drug: PA21']}, {'type': 'EXPERIMENTAL', 'label': 'PA21 2250 mg/day', 'interventionNames': ['Drug: PA21']}, {'type': 'EXPERIMENTAL', 'label': 'PA21 3000 mg/day', 'interventionNames': ['Drug: PA21']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PA21', 'type': 'DRUG', 'armGroupLabels': ['PA21 750 mg/day']}, {'name': 'PA21', 'type': 'DRUG', 'armGroupLabels': ['PA21 1500 mg/day']}, {'name': 'PA21', 'type': 'DRUG', 'armGroupLabels': ['PA21 2250 mg/day']}, {'name': 'PA21', 'type': 'DRUG', 'armGroupLabels': ['PA21 3000 mg/day']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan', 'facility': 'Japan'}], 'overallOfficials': [{'name': 'Tatsuro Takei', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Development Department, Kissei pharmaceutical Co., Ltd.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}