Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 8:19 PM
Study NCT ID:
NCT00824460
Status:
COMPLETED
Last Update Posted:
2014-04-01
First Post:
2009-01-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Phosphate Levels in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
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Any manuscript or abstract proposed by the Investigators must be reviewed and approved in writing by Vifor Pharma before submission for publication. Names of all Investigators participating in the study will be included in the publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'For the serious adverse event (SAE) and adverse event (AE) listings, data from the Safety Set (SS) was used. The SS consists of all randomised subjects who received at least 1 dose of study treatment.', 'eventGroups': [{'id': 'EG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25 g PA21 (1 tablet)', 'otherNumAtRisk': 26, 'otherNumAffected': 13, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': '5.0 g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0 g PA21 (4 tablets)', 'otherNumAtRisk': 26, 'otherNumAffected': 16, 'seriousNumAtRisk': 26, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5 g PA21 (6 tablets)', 'otherNumAtRisk': 25, 'otherNumAffected': 13, 'seriousNumAtRisk': 25, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0 g PA21 (8 tablets)', 'otherNumAtRisk': 27, 'otherNumAffected': 18, 'seriousNumAtRisk': 27, 'seriousNumAffected': 1}, {'id': 'EG004', 'title': '12.5 g PA21 (2,500 mg Iron)', 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'MedDRA (11.1)'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.1)'}], 'seriousEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 0, 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'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}, {'term': 'Diabetic retinopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 11.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Serum-phosphate Levels at the End of Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '24', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25 g PA21 (1 tablet)'}, {'id': 'OG001', 'title': '5.0 g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0 g PA21 (4 tablets)'}, {'id': 'OG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5 g PA21 (6 tablets)'}, {'id': 'OG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0 g PA21 (8 tablets)'}, {'id': 'OG004', 'title': '12.5g PA21 (2,500 mg Iron)', 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efficacy evaluation (while on treatment).\n\nNumber of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 2.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum-phosphate Levels at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}, {'value': '22', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25g PA21 (1 tablet)'}, {'id': 'OG001', 'title': '5.0g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0g PA21 (4 tablets)'}, {'id': 'OG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5g PA21 (6 tablets)'}, {'id': 'OG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0g PA21 (8 tablets)'}, {'id': 'OG004', 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evaluation (while on treatment).\n\nNumber of participants analyzed at this time point includes all subjects that had serum-phosphate measured at Week 4.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Serum-phosphate Levels at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '20', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25 g PA21 (1 tablet)'}, {'id': 'OG001', 'title': '5.0 g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0 g PA21 (4 tablets)'}, {'id': 'OG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5 g PA21 (6 tablets)'}, {'id': 'OG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0 g PA21 (8 tablets)'}, {'id': 'OG004', 'title': '12.5 g PA21 (2,500 mg Iron)', 'description': 'Daily dose of 12.5 g PA21 (10 tablets)'}, {'id': 'OG005', 'title': 'Sevelamer Hydrochloride - Active Control', 'description': 'Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '-0.51', 'spread': '0.62', 'groupId': 'OG001'}, {'value': '-0.40', 'spread': '0.33', 'groupId': 'OG002'}, {'value': '-0.57', 'spread': '0.55', 'groupId': 'OG003'}, {'value': '-0.58', 'spread': '0.58', 'groupId': 'OG004'}, {'value': '-0.52', 'spread': '0.37', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 weeks after baseline', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For this Secondary Outcome, FAS population was used, which consists of all randomized subjects who received at least 1 dose of study treatment and had at least 1 post-baseline efficacy evaluation (while on treatment).\n\nNumber of participants analyzed at this time point includes all subjects that had a serum-phosphate measurement at Week 5.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25 g PA21 (1 tablet)'}, {'id': 'FG001', 'title': '5.0 g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0 g PA21 (4 tablets)'}, {'id': 'FG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5 g PA21 (6 tablets)'}, {'id': 'FG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0 g PA21 (8 tablets)'}, {'id': 'FG004', 'title': '12.5 g PA21 (2,500 mg Iron)', 'description': 'Daily dose of 12.5 g PA21 (10 tablets)'}, {'id': 'FG005', 'title': 'Sevelamer Hydrochloride - Active Control', 'description': 'Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '24'}, {'groupId': 'FG005', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '15'}, {'groupId': 'FG005', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}, {'value': '26', 'groupId': 'BG005'}, {'value': '154', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': '1.25 g PA21 (250 mg Iron)', 'description': 'Daily dose of 1.25 g PA21 (1 tablet)'}, {'id': 'BG001', 'title': '5.0 g PA21 (1,000 mg Iron)', 'description': 'Daily dose of 5.0 g PA21 (4 tablets)'}, {'id': 'BG002', 'title': '7.5 g PA21 (1,500 mg Iron)', 'description': 'Daily dose of 7.5 g PA21 (6 tablets)'}, {'id': 'BG003', 'title': '10.0 g PA21 (2,000 mg Iron)', 'description': 'Daily dose of 10.0g PA21 (8 tablets)'}, {'id': 'BG004', 'title': '12.5g PA21 (2,500 mg Iron)', 'description': 'Daily dose of 12.5 g PA21 (10 tablets)'}, {'id': 'BG005', 'title': 'Sevelamer Hydrochloride - Active Control', 'description': 'Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '12.29', 'groupId': 'BG000'}, {'value': '59.7', 'spread': '13.80', 'groupId': 'BG001'}, {'value': '61.9', 'spread': '13.71', 'groupId': 'BG002'}, {'value': '60.6', 'spread': '12.74', 'groupId': 'BG003'}, {'value': '59.3', 'spread': '12.32', 'groupId': 'BG004'}, {'value': '61.1', 'spread': '11.00', 'groupId': 'BG005'}, {'value': '60.5', 'spread': '12.50', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '57', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '97', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '21', 'groupId': 'BG006'}]}]}, {'title': 'Czech Republic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '40', 'groupId': 'BG006'}]}]}, {'title': 'Russian Federation', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}]}, {'title': 'Bulgaria', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Switzerland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'For baseline characteristics data, from All Randomised patients was used.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'dispFirstSubmitDate': '2012-07-23', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2009-01-09', 'dispFirstSubmitQcDate': '2012-07-31', 'resultsFirstSubmitDate': '2013-12-20', 'studyFirstSubmitQcDate': '2009-01-14', 'dispFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-03-03', 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Serum-phosphate Levels at the End of Treatment.', 'timeFrame': '6 weeks after baseline'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Serum-phosphate Levels at Week 2', 'timeFrame': '2 weeks after baseline'}, {'measure': 'Change From Baseline in Serum-phosphate Levels at Week 4', 'timeFrame': '4 weeks after baseline'}, {'measure': 'Change From Baseline in Serum-phosphate Levels at Week 5', 'timeFrame': '5 weeks after baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hemodialysis'], 'conditions': ['Chronic Kidney Disease']}, '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 investigate the ability of different doses of PA21 to lower serum phosphate levels, in patients with chronic kidney disease on maintenance hemodialysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* ≥ 18 years of age,\n* Receiving stable maintenance hemodialysis 3 times a week\n* On restricted phosphate diet at screening and throughout study\n* Receiving stable dose of phosphate binder for at least 1 month\n* Serum phosphate levels \\>1.78 mmol/L\n\nMain Exclusion Criteria:\n\n* Uncontrolled hyperphosphatemia\n* Hypercalcemia at screening or during washout\n* Serum calcium \\< 1.9 mmol/L (\\<7.6 mg/dL)\n* Severe hyperparathyroidism (iPTH levels \\>600 ng/L)\n* Pregnancy or lactation\n* Iron deficiency anemia\n* History of hemochromatosis or ferritin \\>800 mg/L,\n* Hepatitis B, hepatitis C or other significant concurrent liver disorders\n* Known positivity to HIV\n* Use of oral iron preparations 1 month before screening,\n* Serious medical condition or uncontrolled systemic disease'}, 'identificationModule': {'nctId': 'NCT00824460', 'acronym': 'PA21', 'briefTitle': 'Study of Phosphate Levels in Patients With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'An Open-label, Randomised, Active Controlled Multi-center Phase II Dose Finding Study to Evaluate the Ability of PA21 to Lower Serum Phosphate Levels and the Tolerability in Patients With Chronic Kidney Disease on Maintenance Hemodialysis', 'orgStudyIdInfo': {'id': 'PA-CL-03A'}, 'secondaryIdInfos': [{'id': '75610'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1.25 g PA21', 'interventionNames': ['Drug: 1.25 g PA21 (250 mg iron)']}, {'type': 'EXPERIMENTAL', 'label': '5.0 g PA21', 'interventionNames': ['Drug: 5.0 g PA21 (1,000 mg iron)']}, {'type': 'EXPERIMENTAL', 'label': '7.5 g PA21', 'interventionNames': ['Drug: 7.5 g PA21 (1,500 mg iron)']}, {'type': 'EXPERIMENTAL', 'label': '10.0 g PA21', 'interventionNames': ['Drug: 10.0 g PA21 (2,000 mg iron)']}, {'type': 'EXPERIMENTAL', 'label': '12.5 g PA21', 'interventionNames': ['Drug: 12.5 g PA21 (2,500 mg iron)']}, {'type': 'EXPERIMENTAL', 'label': 'Sevelamer hydrochloride - active control', 'interventionNames': ['Drug: Sevelamer hydrochloride']}], 'interventions': [{'name': '1.25 g PA21 (250 mg iron)', 'type': 'DRUG', 'description': 'Daily dose of 1.25 g PA21 (1 tablet/day) for 6 weeks. One PA21 tablet will be taken orally with the largest meal of the day.', 'armGroupLabels': ['1.25 g PA21']}, {'name': '5.0 g PA21 (1,000 mg iron)', 'type': 'DRUG', 'description': 'Daily dose of 5.0 g PA21 (4 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with the largest meal of the day, and one PA21 tablet will be taken orally with each of the two smaller main meals of the day (3 meals per day).', 'armGroupLabels': ['5.0 g PA21']}, {'name': '7.5 g PA21 (1,500 mg iron)', 'type': 'DRUG', 'description': 'Daily dose of 7.5 g PA21 (6 tablets/day) for 6 weeks. Two PA21 tablets will be taken orally with each of the three main meals of the day (3 meals per day).', 'armGroupLabels': ['7.5 g PA21']}, {'name': '10.0 g PA21 (2,000 mg iron)', 'type': 'DRUG', 'description': 'Daily dose of 10.0 g PA21 (8 tablets/day) for 6 weeks. Four PA21 tablets will be taken orally with the largest meal of the day, and two PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).', 'armGroupLabels': ['10.0 g PA21']}, {'name': '12.5 g PA21 (2,500 mg iron)', 'type': 'DRUG', 'description': 'Daily dose of 12.5 g PA21 (10 tablets/day) for 6 weeks. Four tablets will be taken orally with the largest meal of the day, and three PA21 tablets will be taken orally with each of the two smaller main meals of the day (3 meals per day).', 'armGroupLabels': ['12.5 g PA21']}, {'name': 'Sevelamer hydrochloride', 'type': 'DRUG', 'description': 'Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets/day) for 6 weeks. Two Sevelamer tablets will be taken orally with each of the three main meals of the day (3 meals per day).', 'armGroupLabels': ['Sevelamer hydrochloride - active control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80002', 'city': 'Arvada', 'state': 'Colorado', 'country': 'United States', 'facility': 'Western Nephrology & Metabolic Disease', 'geoPoint': {'lat': 39.80276, 'lon': -105.08748}}, {'zip': '80220', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Complete Renal Care', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Pines Clinical Research', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '11365', 'city': 'Fresh Meadows', 'state': 'New York', 'country': 'United States', 'facility': 'Nephrology Associates', 'geoPoint': {'lat': 40.73482, 'lon': -73.79347}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals / Case Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '37404', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Southeast Renal Research Institute', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37205', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Nephrology Associates', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77099', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Southwest Houston Research', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '5300', 'city': 'Gabrovo', 'country': 'Bulgaria', 'facility': 'MHAT', 'geoPoint': {'lat': 42.87419, 'lon': 25.31823}}, {'zip': '4003', 'city': 'Plovdiv', 'country': 'Bulgaria', 'facility': 'MHAT Plovdiv', 'geoPoint': {'lat': 42.15387, 'lon': 24.75001}}, {'zip': '7002', 'city': 'Rousse', 'country': 'Bulgaria', 'facility': 'Department of Haemodialysis at MHAT', 'geoPoint': {'lat': 43.84872, 'lon': 25.9534}}, {'zip': '1233', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': '5th MHAT Sofia', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1309', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'SHATCVD - National Cardiology Hospital', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1407', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'MHAT "Tokuda Hospital Sofia"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Alexandrovska" Dialysis Clinic', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1431', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Sveti Ivan Rilski"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '1784', 'city': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Sveta Anna"', 'geoPoint': {'lat': 42.69751, 'lon': 23.32415}}, {'zip': '5000', 'city': 'Veliko Tarnovo', 'country': 'Bulgaria', 'facility': 'MDHAT Department of Haemodialysis and Nephrology', 'geoPoint': {'lat': 43.08124, 'lon': 25.62904}}, {'zip': '43000', 'city': 'Bjelovar', 'country': 'Croatia', 'facility': 'Opca bonica Bjelovar', 'geoPoint': {'lat': 45.89789, 'lon': 16.85071}}, {'zip': '47000', 'city': 'Karlovac', 'country': 'Croatia', 'facility': 'Opca bolnica Karlovac', 'geoPoint': {'lat': 45.49167, 'lon': 15.55}}, {'zip': '48000', 'city': 'Koprivnica', 'country': 'Croatia', 'facility': 'Opca bolnica', 'geoPoint': {'lat': 46.16364, 'lon': 16.8297}}, {'zip': '31000', 'city': 'Osijek', 'country': 'Croatia', 'facility': 'Klinicka bolnica Osijek', 'geoPoint': {'lat': 45.55066, 'lon': 18.6942}}, {'zip': '51000', 'city': 'Rijeka', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Rijeka', 'geoPoint': {'lat': 45.32673, 'lon': 14.44241}}, {'zip': '21000', 'city': 'Split', 'country': 'Croatia', 'facility': 'Klinicki bolnicki centar Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}, {'zip': '23000', 'city': 'Zadar', 'country': 'Croatia', 'facility': 'Opca bolnica Zadar', 'geoPoint': {'lat': 44.11578, 'lon': 15.22514}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinicka bolnica', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10000', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Poliklinika Sveti Duh II', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '10040', 'city': 'Zagreb', 'country': 'Croatia', 'facility': 'Klinicka bolnica Dubrava', 'geoPoint': {'lat': 45.81444, 'lon': 15.97798}}, {'zip': '60200', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Innef a.s. 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