Ignite Creation Date:
2025-12-24 @ 1:16 PM
Ignite Modification Date:
2026-02-20 @ 12:41 PM
Study NCT ID:
NCT02661295
Status:
TERMINATED
Last Update Posted:
2023-04-20
First Post:
2016-01-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ferric Citrate to Improve Inflammation and Lipid Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}, {'id': 'D054559', 'term': 'Hyperphosphatemia'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'candace.grant@nyulangone.org', 'phone': '516-663-0333', 'title': 'Candace Grant, MD', 'phoneExt': '9054', 'organization': 'NYU Langone Health'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 1, 'seriousNumAffected': 14}], 'seriousEvents': [{'term': 'Renal transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Coronary artery bypass graft', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Encephalomalacia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Spinal Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Arteriovenous fistula site complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acetabulum fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Catheter infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percent Change in Total Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'spread': '33.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in total cholesterol (mg/dl) from Baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in LDL-Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.05', 'spread': '32.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in HDL Cholesterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '6.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in Triglycerides', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.11', 'spread': '67.69', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in triglycerides (mg/dl) from baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in TNF-alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.77', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.78', 'spread': '19.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '101.96', 'spread': '422.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in Ferritin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.11', 'spread': '296.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in ferritin (ng/ml) from baseline to Month 6.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.89', 'spread': '35.49', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in C-reactive Protein (mg/L) from baseline to Month 6.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percent Change in Homocysteine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.35', 'spread': '7.31', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in homocysteine (micromol/L) from baseline to Month 6.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Intravenous Iron Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-588.8', 'spread': '807.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in intravenous iron use (mg) from Baseline to Month 6.', 'unitOfMeasure': 'mg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Calcium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.08', 'spread': '0.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in calcium (mg/dL) from baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Phosphorus', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.58', 'spread': '1.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in phosphorus (md/dl) from baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Parathyroid Hormone (PTH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.47', 'spread': '280.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in PTH (pg/ml) from baseline to Month 6.', 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Transferred Out', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Kidney Transplant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawn due to side effects', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawn due to access type', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawn due to allergies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawn due to non-compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Failed screening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.\n\nFerric Citrate: Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.8', 'spread': '15.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-04-28', 'size': 472474, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T15:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study will be designed as a single arm, prospective, experimental trial of 45 hemodialysis patients. Patients on hemodialysis at least 6 months and receiving a phosphate binder with serum phosphorus levels between 2.5 and 8.0 mg/dL, normal serum calcium levels, and on maintenance iron therapy are potentially eligible. Participants will receive ferric citrate after at least a 2 week washout period from previous phosphate binders if phosphorus is ≥ 5.5 mg/dl, calcium is within the normal range and ferritin ≥ 200 and \\< 600 ng/ml. Ferric citrate will be titrated to maintain serum phosphorus and calcium within acceptable levels. Inflammatory markers and lipid levels will be tested at 0, 3, and 6 months.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'whyStopped': '38 enrolled, 19 completed the study when loss of funding occurred', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2016-01-11', 'resultsFirstSubmitDate': '2023-03-30', 'studyFirstSubmitQcDate': '2016-01-18', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-30', 'studyFirstPostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent Change in Total Cholesterol', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in total cholesterol (mg/dl) from Baseline to Month 6.'}, {'measure': 'Percent Change in LDL-Cholesterol', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in low-density lipoprotein (LDL) cholesterol (mg/dl) from baseline to Month 6'}, {'measure': 'Percent Change in HDL Cholesterol', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in high-density lipoprotein (HDL) cholesterol (mg/dl) from baseline to Month 6.'}, {'measure': 'Percent Change in Triglycerides', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in triglycerides (mg/dl) from baseline to Month 6.'}, {'measure': 'Percent Change in TNF-alpha', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in tumor necrosis factor (TNF)-alpha (pg/ml) from Baseline to Month 6.'}, {'measure': 'Percent Change in IL-6', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in interleukin 6 (IL-6) (pg/ml) from baseline to Month 6'}, {'measure': 'Percent Change in IL-8', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in interleukin 8 (IL-8) (pg/ml) from baseline to Month 6.'}, {'measure': 'Percent Change in Ferritin', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in ferritin (ng/ml) from baseline to Month 6.'}, {'measure': 'Percent Change in C-reactive Protein', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in C-reactive Protein (mg/L) from baseline to Month 6.'}, {'measure': 'Percent Change in Homocysteine', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in homocysteine (micromol/L) from baseline to Month 6.'}, {'measure': 'Change in Intravenous Iron Use', 'timeFrame': 'Baseline, Month 6', 'description': 'Change in intravenous iron use (mg) from Baseline to Month 6.'}], 'secondaryOutcomes': [{'measure': 'Percent Change in Calcium', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in calcium (mg/dL) from baseline to Month 6.'}, {'measure': 'Percent Change in Phosphorus', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in phosphorus (md/dl) from baseline to Month 6.'}, {'measure': 'Percent Change in Parathyroid Hormone (PTH)', 'timeFrame': 'Baseline, Month 6', 'description': 'Percent change in PTH (pg/ml) from baseline to Month 6.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['End Stage Renal Disease', 'Hyperphosphatemia', 'Chronic Inflammation']}, 'descriptionModule': {'briefSummary': 'The risk of cardiovascular mortality in patients with end stage renal disease on hemodialysis is 10-100 times higher than the normal population. This is due in part to high levels of inflammation and vascular calcification found in these patients. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.', 'detailedDescription': 'In patients with end stage renal disease (ESRD) receiving dialysis, the risk of cardiovascular death has been estimated to be 10-100 times higher than the general population without renal disease. This is due in part to high levels of inflammation and vascular calcification (large deposits of calcium in arteries) found in these patients. Chronic inflammation is particularly common in patients with ESRD. Parenteral iron therapy, which is common in patients on dialysis, may contribute to this inflammation and also a higher cardiovascular risk. Phosphate binders, particularly non-calcium based phosphate binders, may decrease cardiovascular risk by decreasing inflammation and vascular calcification. In a study of 10,044 hemodialysis patients, treatment with a phosphate binder was associated with improved survival. Ferric citrate a non-calcium based phosphate binder with approximately 210 mg of ferric iron has recently been approved for patients on hemodialysis. It has been shown to improve serum phosphorus levels and decrease intravenous iron requirements for patients on hemodialysis. The effect of this phosphate binder on inflammation and lipid levels is unknown but investigators hypothesize that ferric citrate has the potential to improve inflammation and lipid levels in patients on hemodialysis by decreasing intravenous iron requirements and by improving lipid metabolism.\n\nFerric citrate has the potential to decrease cardiovascular risk through multiple mechanisms:\n\n1. acting as a non-calcium based binder to decrease serum phosphorus levels and vascular calcification,\n2. decreasing intravenous iron requirements which in turn may decrease inflammation,\n3. binding endotoxin (a harmful substance produced by microorganisms) in the gut and\n4. improving lipid metabolism.\n\nThe purpose of this study is to examine the effect of ferric citrate on inflammatory markers and lipid levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemodialysis treatment for ≥ 6 months\n* Phosphate binder treatment for ≥ to 1 month\n* Maintenance iron therapy with no more than 125mg IV iron weekly≥ to 1 month\n* Serum phosphorus levels between 2.5 and 8 at screening\n* Serum phosphorus ≥ to 6.0 mg/dL after a 2 week washout period.\n* Serum ferritin ≥ 200 and \\< 600ng/ml after a 2 week washout period\n* Serum calcium levels within normal range\n* Predicted survival greater than 6 months\n\nExclusion Criteria:\n\n* Intact PTH\\< 70 pg/ml or \\> 1,000 pg/ml\n* Oral iron use\n* Vitamin C supplement use\n* Parathyroidectomy\n* Active malignancy\n* Hemodialysis via an intravenous catheter or arteriovenous (AV) graft\n* Received \\> 250mg of IV iron over the two weeks prior to screening\n* Whole blood transfusion within 3 months prior to screening\n* Active bleeding other than from the dialysis access\n* Hospitalization within one month prior to screening\n* current infection\n* Ongoing or uncontrolled inflammatory disorder\n* Liver cirrhosis\n* Likelihood of imminent renal transplantation'}, 'identificationModule': {'nctId': 'NCT02661295', 'briefTitle': 'A Study of Ferric Citrate to Improve Inflammation and Lipid Levels', 'organization': {'class': 'OTHER', 'fullName': 'Winthrop University Hospital'}, 'officialTitle': 'The Effect of Ferric Citrate on Inflammation and Lipid Levels in Patients on Hemodialysis', 'orgStudyIdInfo': {'id': 'WUH 756275-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ferric Citrate', 'description': 'Ferric citrate at a starting dose of 2 tablets with each meal will be given to all participants.', 'interventionNames': ['Drug: Ferric Citrate']}], 'interventions': [{'name': 'Ferric Citrate', 'type': 'DRUG', 'otherNames': ['Auryxia'], 'description': 'Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and \\< 50% and ferritin ≥ 200 and \\< 500 ng/ml after a 2 week wash out period.', 'armGroupLabels': ['Ferric Citrate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11501', 'city': 'Mineola', 'state': 'New York', 'country': 'United States', 'facility': 'Winthrop University Hospital', 'geoPoint': {'lat': 40.74927, 'lon': -73.64068}}], 'overallOfficials': [{'name': 'Candace Grant, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Winthrop'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Winthrop University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Keryx Biopharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}