Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-31 @ 3:39 PM
Study NCT ID:
NCT01850602
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2013-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia
Sponsor:
Organization:
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069603', 'term': 'Sevelamer'}], 'ancestors': [{'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, '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': '12 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'PA21', 'description': 'PA21', 'otherNumAtRisk': 108, 'deathsNumAtRisk': 108, 'otherNumAffected': 47, 'seriousNumAtRisk': 108, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride', 'otherNumAtRisk': 105, 'deathsNumAtRisk': 105, 'otherNumAffected': 42, 'seriousNumAtRisk': 105, 'deathsNumAffected': 0, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 24}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Colon cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastric cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventricular tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal cyst ruptured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Shunt stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 108, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 105, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'OG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}], 'classes': [{'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '4.80', 'upperLimit': '5.19'}, {'value': '5.34', 'groupId': 'OG001', 'lowerLimit': '5.13', 'upperLimit': '5.55'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.34', 'ciLowerLimit': '-0.63', 'ciUpperLimit': '-0.05', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Non-Inferiority margin: 1.0 mg/dL\n\nNon-Inferiority was considerd to be confirmed if the upper limit of two-sided confidence interval became 1.0 mg/dL or less.'}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'description': 'Covariate: Serum phosphorus concentrations at baseline.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'OG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}], 'classes': [{'categories': [{'measurements': [{'value': '5.01', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '5.33', 'spread': '1.03', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'OG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}], 'classes': [{'categories': [{'measurements': [{'value': '9.14', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '8.91', 'spread': '0.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}, {'type': 'SECONDARY', 'title': 'Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'OG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}], 'classes': [{'categories': [{'measurements': [{'value': '203.6', 'spread': '117.1', 'groupId': 'OG000'}, {'value': '253.1', 'spread': '168.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'FG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '108'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '94'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Decrease in serum calcium', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Increase in serum ferritin', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'PA21', 'description': 'PA21'}, {'id': 'BG001', 'title': 'Sevelamer Hydrochloride', 'description': 'Sevelamer hydrochloride'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.0', 'spread': '11.7', 'groupId': 'BG000'}, {'value': '60.8', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '60.9', 'spread': '11.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Dialysis vintage', 'classes': [{'categories': [{'measurements': [{'value': '104.9', 'spread': '79.7', 'groupId': 'BG000'}, {'value': '102.4', 'spread': '90.6', 'groupId': 'BG001'}, {'value': '103.7', 'spread': '84.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Per Protocol Set'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 213}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2013-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-02', 'studyFirstSubmitDate': '2013-05-07', 'resultsFirstSubmitDate': '2018-03-02', 'studyFirstSubmitQcDate': '2013-05-08', 'lastUpdatePostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-02', 'studyFirstPostDateStruct': {'date': '2013-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adjusted Mean of Serum Phosphorus Concentrations at the End of Treatment', 'timeFrame': '12 weeks', 'description': 'Covariate: Serum phosphorus concentrations at baseline.'}], 'secondaryOutcomes': [{'measure': 'Serum Phosphorus Concentrations at End of Treatment (Actual Measured Value)', 'timeFrame': '12 weeks'}, {'measure': 'Corrected Serum Calcium Concentrations at End of Treatment (Actual Measured Value)', 'timeFrame': '12 weeks'}, {'measure': 'Serum Intact-PTH Concentrations at End of Treatment (Actual Measured Value)', 'timeFrame': '12 weeks'}]}, 'conditionsModule': {'keywords': ['Hemodialysis', 'Hyperphosphatemia'], 'conditions': ['Hemodialysis', 'Hyperphosphatemia']}, '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': 'The purpose of this study is to evaluate the efficacy and safety of PA21 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': 'NCT01850602', 'briefTitle': 'A Phase III Study of PA21 in Hemodialysis Patients With Hyperphosphatemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kissei Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': 'PA1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA21', 'interventionNames': ['Drug: PA21']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sevelamer hydrochloride', 'interventionNames': ['Drug: Sevelamer hydrochloride']}], 'interventions': [{'name': 'PA21', 'type': 'DRUG', 'armGroupLabels': ['PA21']}, {'name': 'Sevelamer hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['Sevelamer hydrochloride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Japan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kissei Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}