Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:41 PM
Study NCT ID:
NCT02268994
Status:
COMPLETED
Last Update Posted:
2018-03-22
First Post:
2014-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'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': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C025314', 'term': 'ferric citrate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@keryx.com', 'phone': '1-844-44-KERYX (844-445-3799)', 'title': 'Keryx Medical Information', 'organization': 'Keryx Biopharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 Week Randomized Period', 'eventGroups': [{'id': 'EG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 61, 'seriousNumAtRisk': 117, 'deathsNumAffected': 2, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo', 'otherNumAtRisk': 116, 'deathsNumAtRisk': 116, 'otherNumAffected': 41, 'seriousNumAtRisk': 116, 'deathsNumAffected': 0, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 19}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 15}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Faeces Discoloured', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Iron Deficiency Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardio-Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sick Sinus Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Failure Congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Colitis Ischaemic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholangitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clostridium Difficle Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abscess Limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Tract Infection Fungal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Celluitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Osteomyelitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Procedural Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood Glucose Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic Ketoacidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fluid Overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metabolic Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Status Epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hydronephrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Respiratory Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chronic Obstructive Pulmonary Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Toe Amputation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 117, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 116, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 gr ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.39', 'spread': '0.054', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.056', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.', 'unitOfMeasure': 'g/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '0.67', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.', 'unitOfMeasure': '% saturation', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Ferritin at the End of 16 Weeks Minus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 gr of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '68.1', 'spread': '3.99', 'groupId': 'OG000'}, {'value': '-6.1', 'spread': '4.10', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.28', 'spread': '0.036', 'groupId': 'OG000'}, {'value': '-0.14', 'spread': '0.037', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '117'}, {'groupId': 'FG001', 'numSubjects': '116'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '35'}]}]}], 'preAssignmentDetails': '1 randomized subject was excluded because they did not receive study drug and were excluded from the safety population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'KRX-0502 (Ferric Citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron\n\nferric citrate: 1 g ferric citrate containing approximately 210 mg of ferric iron'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Matching Placebo\n\nPlacebo: Matching placebo'}, {'id': 'BG002', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '11.15', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '13.08', 'groupId': 'BG001'}, {'value': '65.4', 'spread': '12.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '88', 'groupId': 'BG000'}, {'value': '92', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '82', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 234}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'dispFirstSubmitDate': '2017-03-09', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-22', 'studyFirstSubmitDate': '2014-10-11', 'dispFirstSubmitQcDate': '2017-03-09', 'resultsFirstSubmitDate': '2017-11-30', 'studyFirstSubmitQcDate': '2014-10-16', 'dispFirstPostDateStruct': {'date': '2017-03-10', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-23', 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects Achieving an Increase in Hemoglobin of ≥1.0 g/dL at Any Time Point Between Baseline and the End of the 16-week Randomized Period', 'timeFrame': 'Week 16', 'description': 'Efficacy analyses were performed for the Intention-to-treat (ITT) population, the population consisted of all subjects who were randomized, had a baseline laboratory value, took at least 1 dose of study drug, and had at least 1 post-baseline laboratory assessment during the randomized period.'}], 'secondaryOutcomes': [{'measure': 'Mean Change in Hemoglobin (Hgb) at the End of 16 Weeks Minus Baseline', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of Hgb at 16 weeks compared to the Hgb value at the time of study entry.'}, {'measure': 'Mean Change in Transferrin Saturation (TSAT) at the End of 16 Weeks Minus Baseline', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of TSAT at 16 weeks compared to the TSAT value at the time of study entry was averaged.'}, {'measure': 'Mean Change in Ferritin at the End of 16 Weeks Minus Baseline', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of ferritin at 16 weeks compared to the ferritin value at the time of study entry.'}, {'measure': 'Percentage of Subjects Experiencing a Sustained Treatment Effect on Hemoglobin (Hgb)', 'timeFrame': 'Week 16', 'description': 'Proportion of subjects that continued to maintain an increase in Hgb over a 4 week period, provided they had an increase of at least 1.0 g/dL during that 4-week period'}, {'measure': 'Mean Change in Serum Phosphate at the End of 16 Weeks Minus Baseline', 'timeFrame': 'Baseline and week 16', 'description': 'The difference of serum phosphate at 16 weeks compared to the serum phosphate value at the time of study entry.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ferric citrate', 'Chronic kidney disease', 'Anemia'], 'conditions': ['Anemia of 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': 'a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period").', 'detailedDescription': 'a 24-week phase 3, multi-center clinical trial, comprised of a 16-week, randomized, double-blind, placebo-controlled period ("Randomized Period"), followed by an 8-week open-label safety extension period, where all subjects receive KRX-0502 (ferric citrate) ("Extension Period"). The study will consist of 14 clinic visits over a period of 24 weeks. There will be a screening period of up to 14 days; Approximately 230 subjects will be randomized into the Randomized Period in a 1:1 ratio to receive either KRX-0502 or matching placebo, at baseline'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Men and non-lactating women with negative serum pregnancy test (for women of child-bearing potential) at Screening\n2. Age ≥18 years\n3. CKD with Estimated Glomerular Filtration Rate (eGFR) \\<60 mL/min at Screening using the 4-variable Modification of Diet in Renal Disease (MDRD) equation (with a limit of up to 20% of the target randomization of 230 subjects with eGFR \\<15 mL/min)\n4. Patients who were intolerant of or have had an inadequate therapeutic response to oral iron supplements (in the opinion of the investigator)\n5. Hgb ≥ 9.0 g/dL and ≤11.5 g/dL at Screening\n6. Serum ferritin ≤200 ng/mL and Transferrin Saturation (TSAT) ≤25% at Screening\n7. Serum Intact Parathyroid Hormone (iPTH) ≤600 pg/mL at Screening\n8. Must consume a minimum of 2 meals per day\n9. Willing and able to give written informed consent\n\nExclusion Criteria:\n\n1. Serum phosphate \\<3.5 mg/dL at Screening\n2. Liver enzymes (ALT/AST) \\>X3 times upper limit of normal at Screening\n3. Symptomatic gastrointestinal bleeding or inflammatory bowel disease within 12 weeks prior to Screening\n4. Evidence of acute kidney injury or requirement for dialysis within 12 weeks prior to Screening\n5. Scheduled kidney transplant or initiation of dialysis planned within 24 weeks of Screening\n6. IV iron administered within 4 weeks prior to Screening\n7. Erythropoiesis-stimulating agent (ESA) administered within 4 weeks prior to Screening\n8. Blood transfusion within 4 weeks prior to Screening\n9. Receipt of any investigational drug within 4 weeks prior to Screening\n10. Cause of anemia other than iron deficiency or chronic kidney disease\n11. Malignancy (except non-melanoma skin cancer or disease-free for ≥2 years after curative therapy)\n12. History of hemochromatosis\n13. Active drug or alcohol dependence or abuse (excluding tobacco use or medicinal marijuana) within the 12 months prior to Screening or evidence of such abuse (in the opinion of the PI)\n14. Subjects with known allergic reaction to previous oral iron therapy\n15. Previous intolerance to oral ferric citrate\n16. Psychiatric disorder that interferes with the subject's ability to comply with the study protocol\n17. Planned surgery or hospitalization (anticipated to last \\>72 hours) during the randomized period of the trial other than dialysis access related surgery.\n18. Any other medical condition that, in the opinion of the PI, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject\n19. Inability to cooperate with study personnel"}, 'identificationModule': {'nctId': 'NCT02268994', 'briefTitle': 'KRX-0502 (Ferric Citrate) for the Treatment of IDA in Adult Subjects With NDD-CKD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Keryx Biopharmaceuticals'}, 'officialTitle': 'A Phase 3 Study of KRX-0502 (Ferric Citrate) for the Treatment of Iron Deficiency Anemia (IDA) in Adult Subjects With Non-Dialysis Dependent (NDD) Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'KRX-0502-306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KRX-0502 (ferric citrate)', 'description': '1 g of KRX-0502 (ferric citrate) containing approximately 210 mg of ferric iron', 'interventionNames': ['Drug: ferric citrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Matching Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ferric citrate', 'type': 'DRUG', 'otherNames': ['KRX-0502'], 'description': '1 g ferric citrate containing approximately 210 mg of ferric iron', 'armGroupLabels': ['KRX-0502 (ferric citrate)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85027', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'AKDHC Medical Research Services, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85284', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Southwest Kidney Institute', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '91204', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'California Renal Research', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '90623', 'city': 'La Palma', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Medical Research Center', 'geoPoint': {'lat': 33.8464, 'lon': -118.04673}}, {'zip': '90022', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Academic Medical Research Institute, Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92505', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Apex Research of Riverside', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Capital Nephrology Medical Group', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92103', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'La Jolla Clinical Research, Inc', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'California Institute of Renal Research', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80230', 'city': 'Denver', 'state': 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'Texas', 'country': 'United States', 'facility': 'Clinical Advancement Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Kidney Disease Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '22304', 'city': 'Alexandria', 'state': 'Virginia', 'country': 'United States', 'facility': 'Mendez Center for Clinical Research', 'geoPoint': {'lat': 38.80484, 'lon': -77.04692}}, {'zip': '22033', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Nephrology Associates of Northern VA, Inc.', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '23666', 'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'facility': 'Peninsula Kidney Associates', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}], 'overallOfficials': [{'name': 'Geoffrey Block, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Denver Nephrology'}, {'name': 'Glenn Chertow, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Division of Nephrology at Stanford University School of Medicine'}, {'name': 'Steven Fishbane, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Kidney Disease and Hypertension at North Shore University Hospital/Long Island Jewish Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Keryx Biopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}