Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-30 @ 4:58 AM
Study NCT ID:
NCT03079869
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2017-03-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2021-10-20', 'type': 'ACTUAL'}}}}, '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': 'C025314', 'term': 'ferric citrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RE-CTCAT@kp.org', 'phone': '626-720-7463', 'title': 'KPSC PRS Administrator', 'organization': 'Kaiser Permanente'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '7 months', 'description': "Adverse event (AE's) were included for all patient who received study drug for at least 1 day (n=54). After the baseline visit adverse events are collected on a weekly basis for the hemodialysis patients, and on a bi-monthly basis from the dialysis patients, and again 30days after the termination of the study.", 'eventGroups': [{'id': 'EG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 23, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.', 'otherNumAtRisk': 27, 'deathsNumAtRisk': 27, 'otherNumAffected': 27, 'seriousNumAtRisk': 27, 'deathsNumAffected': 0, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Black stool', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bloating/Gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea, vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 3}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Itching/rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest Pain/Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Arteriovenous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Congestive heart failure exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'gallstone pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematochezia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peritonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right foot infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'notes': 'non-cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intertrochanteric fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left foot pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right hip osteoporotic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Laparoscopic right nephrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Placement of catheter for HD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Right sided pleuroperitoneal leak', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Left heel ulcers', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Critical limb ischemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hemorrhagic cerebrovascular accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral vascular disease', 'notes': 'from diabetes mellitus type 2', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phosphorus Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'OG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}], 'classes': [{'title': 'Pre-treatment', 'categories': [{'measurements': [{'value': '5.3', 'spread': '1', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'On-treatment', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '6', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment'}, {'type': 'SECONDARY', 'title': 'Intravenous (IV) Iron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'OG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '249.2', 'spread': '215.6', 'groupId': 'OG000'}, {'value': '21.2', 'spread': '43.1', 'groupId': 'OG001'}]}]}, {'title': 'On-Treatment', 'categories': [{'measurements': [{'value': '102', 'spread': '137.5', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '33.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.', 'unitOfMeasure': 'mg/mo', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and on-treatment.'}, {'type': 'SECONDARY', 'title': 'Erythropoiesis Stimulating Agents (ESA) Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'OG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}], 'classes': [{'title': 'Pre-Treatment', 'categories': [{'measurements': [{'value': '28761.1', 'spread': '41314.1', 'groupId': 'OG000'}, {'value': '16724.4', 'spread': '14042.3', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '16525.8', 'spread': '16917', 'groupId': 'OG000'}, {'value': '16780.1', 'spread': '13433.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.', 'unitOfMeasure': 'units/mo', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts. Wilcoxon signed rank test was used to compare pre-treatment and post-treatment.'}, {'type': 'SECONDARY', 'title': 'Median Pill Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'OG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}], 'classes': [{'title': 'Phosphate binder pill count prior to Ferric Citrate use', 'categories': [{'measurements': [{'value': '9.5', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '13.8'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '6.0', 'upperLimit': '9.0'}]}]}, {'title': 'Phosphate binder pill count during Ferric Citrate use', 'categories': [{'measurements': [{'value': '6.0', 'groupId': 'OG000', 'lowerLimit': '4.5', 'upperLimit': '9.0'}, {'value': '4.5', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'median pill count of ferric citrate pills/day required to maintain phosphorus control', 'unitOfMeasure': 'tablets per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The final analysis included 21 Hemodialysis and 26 Peritoneal Dialysis patients after exclusion of early dropouts.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'FG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '27'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol withdrawal criteria-off drug > 2 weeks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Study subjects who received either hemodialysis (HD) or peritoneal dialysis (PD) at Kaiser Permanente Southern California, Los Angeles Medical Center were eligible for recruitment.', 'preAssignmentDetails': 'No pre-assignment events. 55 subjects were enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferric Citrate - Hemodialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'BG001', 'title': 'Ferric Citrate - Peritoneal Dialysis', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.\n\nFerric Citrate: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65', 'spread': '13', 'groupId': 'BG000'}, {'value': '57', 'spread': '14', 'groupId': 'BG001'}, {'value': '60', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'Unknown Race', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}, {'title': 'Unknown Ethnicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '28.4', 'spread': '4.7', 'groupId': 'BG000'}, {'value': '27.8', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '28.1', 'spread': '4.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Smoking', 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Duration on Dialysis', 'classes': [{'categories': [{'measurements': [{'value': '29', 'spread': '32.1', 'groupId': 'BG000'}, {'value': '41.4', 'spread': '49.2', 'groupId': 'BG001'}, {'value': '36.2', 'spread': '42.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Cerebrovascular Disease', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ischemic Heart Failure', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Peripheral Vascular Disease', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'A total of 28 Hemodialysis (HD) patients were enrolled. Of these, 2 patients withdrew prior to receiving the study drug, 3 patients withdrew within the first 2 weeks due to adverse event, 2 patients withdrew themselves after 1 day. Only 1 of the 27 Peritoneal Dialysis (PD) patients enrolled in the study withdrew.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-05', 'size': 475682, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-09-23T20:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2019-09-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2017-03-01', 'resultsFirstSubmitDate': '2021-09-23', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-01-03', 'studyFirstPostDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phosphorus Levels', 'timeFrame': '6 months', 'description': 'Serum phosphorus levels measured by mg/dL from the 6 months prior to enrollment were compared to serum phosphorus levels collected during the 6 months of ferric citrate use'}], 'secondaryOutcomes': [{'measure': 'Intravenous (IV) Iron', 'timeFrame': '6 months', 'description': 'The amount of intravenous (IV) iron in mg used per month by participants for 6 months before and 6 months on Ferric Citrate treatment.'}, {'measure': 'Erythropoiesis Stimulating Agents (ESA) Dose', 'timeFrame': '6 months', 'description': 'Mean Erythropoiesis Stimulating Agents (ESA) use from the 6 months prior to enrollment were compared to ESA use during the 6 months of ferric citrate use. The mean ESA dose units given to each participant per month was used in the analysis of this outcome.'}, {'measure': 'Median Pill Count', 'timeFrame': '6 months', 'description': 'median pill count of ferric citrate pills/day required to maintain phosphorus control'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperphosphatemia']}, 'descriptionModule': {'briefSummary': 'Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California', 'detailedDescription': 'PROTOCOL SUMMARY\n\nTitle: Transition to Ferric Citrate among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study from Kaiser Permanente Southern California\n\nShort Title: FeCitrate\n\nProtocol Number: KP FeCitrate\n\nStudy Phase: 4\n\nStudy Site(s): Los Angeles Kaiser Sunset Medical Center\n\nNumber of Subjects: 55\n\nStudy Arms: 1\n\nIndication: Hyperphosphatemia in end stage renal disease\n\nPrimary Purpose: To evaluate the efficacy of ferric citrate for control of serum phosphorus levels and maintenance of adequate iron stores among dialysis-dependent patients before and after conversion from traditional phosphate binders in a "real world" environment\n\nOverview of Study Design: Prospective non-randomized cohort study of 6-9 months duration (active study period 6 months).\n\nInvestigational Product Administration: One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.\n\nStudy Endpoint: Mean serum phosphorus levels and rate of successful phosphorus control (\\<5.5mg/dl) 6 months before and after treatment with ferric citrate\n\nStatistical Methods: Not powered to detect statistical significance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently using 3 to 18 pills per day of calcium acetate, sevelamer, lanthanum, or calcium carbonate\n* Mean serum phosphorus 4.0-\\<8.0 mg/dl for 6 months prior to enrollment\n* No allergy to iron\n* Mean corrected serum calcium \\> 8.0 mg/dl for 6 months prior to enrollment\n* Mean PTH \\< 1000 pg/ml for 6 months prior to enrollment\n* Mean ferritin \\< 1500 ng/ml and mean iron sat \\< 50% for 6 months prior to enrollment\n\nExclusion Criteria:\n\n* History of gastrointestinal bleeding within past 6 months\n* History of hospitalization for gastroparesis, bowel obstruction, or abdominal surgery within past 6 months\n* Acute kidney injury equal to or less than 3 months before the initial screening date\n* Active malignancy\n* Functioning renal transplant\n* Patients with iron overload syndrome (e.g., Hemochromatosis)\n* History autoimmune disease, hemoglobinopathy, hemochromatosis, sickle cell disease\n* Active or past history of calciphylaxis'}, 'identificationModule': {'nctId': 'NCT03079869', 'briefTitle': 'Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Kaiser Permanente'}, 'officialTitle': 'Transition to Ferric Citrate Among Hemodialysis and Peritoneal Dialysis Patients: A Phase 4 "Real World" Experience Study From Kaiser Permanente Southern California', 'orgStudyIdInfo': {'id': 'FeCitrate'}, 'secondaryIdInfos': [{'id': '11035', 'type': 'OTHER', 'domain': 'Kaiser Permanente Southern California IRB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ferric Citrate', 'description': 'Auryxia, 210 mg ferric iron tablets equivalent to 1 g of ferric citrate are supplied as 200 tablets in 400-cc high-density polyethylene bottles.', 'interventionNames': ['Drug: Ferric Citrate']}], 'interventions': [{'name': 'Ferric Citrate', 'type': 'DRUG', 'otherNames': ['Auryxia'], 'description': 'One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.', 'armGroupLabels': ['Ferric Citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente Los Angeles Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Victoria Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaiser Permanente'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaiser Permanente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Keryx Biopharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}