Viewing Study NCT02968368

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Ignite Creation Date: 2025-12-24 @ 5:45 PM
Ignite Modification Date: 2026-02-28 @ 11:15 AM
Study NCT ID: NCT02968368
Status: COMPLETED
Last Update Posted: 2020-11-02
First Post: 2016-08-30
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], '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': 'D000747', 'term': 'Anemia, Hypochromic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000090463', 'term': 'Iron Deficiencies'}, {'id': 'D019189', 'term': 'Iron Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C062088', 'term': 'ferric maltol'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jmitchell@shieldtx.com', 'phone': '+44 (0) 191 511 8515', 'title': 'Jackie Mitchell MA DPhil', 'organization': 'Shield Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '16 week double blind phase', 'description': '167 subjects. Definitions of AEs and SAEs in line with clintrials.gov definitions', 'eventGroups': [{'id': 'EG000', 'title': 'Oral Ferric Maltol DB', 'description': '30mg capsules BID\n\nFerric maltol\n\ndouble blind phase', 'otherNumAtRisk': 111, 'deathsNumAtRisk': 111, 'otherNumAffected': 75, 'seriousNumAtRisk': 111, 'deathsNumAffected': 75, 'seriousNumAffected': 23}, {'id': 'EG001', 'title': 'Oral Placebo DB', 'description': 'Matching placebo capsules BID\n\nPlacebo\n\ndouble blind phase', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 42, 'seriousNumAtRisk': 56, 'deathsNumAffected': 42, 'seriousNumAffected': 12}, {'id': 'EG002', 'title': 'Oral Ferric Maltol OL', 'description': '30mg capsules BID\n\nFerric maltol\n\nopen label phase', 'otherNumAtRisk': 86, 'deathsNumAtRisk': 86, 'otherNumAffected': 76, 'seriousNumAtRisk': 86, 'deathsNumAffected': 76, 'seriousNumAffected': 27}, {'id': 'EG003', 'title': 'Oral Placebo OL', 'description': 'Matching placebo capsules BID\n\nPlacebo\n\nopen label phase', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 35, 'seriousNumAtRisk': 39, 'deathsNumAffected': 35, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 14}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Feces discolored', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Metabolism and nutrition disorders', 'notes': 'TEAEs in \\<5% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 25}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 6}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infections and infestations', 'notes': 'TEAEs in \\<5% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 39}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Renal and urinary disorders', 'notes': 'TEAEs in \\<5% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Blood and lymphatic system disorders', 'notes': 'TEAEs in \\<5% of Subjects Overall by SOC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 48}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'General disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 9}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Injury, poisoning, and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 17}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 4}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory, thoracic, and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 19}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 5}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 3}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Sudden death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hemorrhagic anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Iron deficiency anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrioventricular block complete', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Failure to thrive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fluid overload', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diverticulum intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Duodenal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 86, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 39, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastritis erosive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 111, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}, {'groupId': 'EG002', 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{'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Change in Hb Concentration From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.53', 'spread': '0.901', 'groupId': 'OG000'}, {'value': '0.00', 'spread': '0.909', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Change in Hemoglobin concentration from baseline to Week 8', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Where a subject had dropped from the study, we used a LOCF by MI methodology to impute values. Therefore the number of subjects and observations at a given time-point may differ.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '16 weeks', 'description': 'Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT'}, {'type': 'SECONDARY', 'title': 'Changes in Ferritin From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '33.13', 'spread': '6.166', 'groupId': 'OG000'}, {'value': '-5.90', 'spread': '9.137', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0006', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.03', 'ciLowerLimit': '17.070', 'ciUpperLimit': '60.992', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '11.097', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline to week 16', 'description': 'Changes in iron parameter - ferritin - from baseline to week 16', 'unitOfMeasure': 'ug/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT OC'}, {'type': 'SECONDARY', 'title': 'Number of Participants With (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': 'Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety population'}, {'type': 'SECONDARY', 'title': 'Changes in TSAT From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4.32', 'spread': '0.719', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.060', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0007', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.46', 'ciLowerLimit': '1.928', 'ciUpperLimit': '7.001', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.282', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline to week 16', 'description': 'Changes in iron parameters - TSAT - from baseline to week 16', 'unitOfMeasure': 'TSAT (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT OC'}, {'type': 'SECONDARY', 'title': 'Changes in Iron Parameter From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '0.397', 'groupId': 'OG000'}, {'value': '0.01', 'spread': '0.586', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0098', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.86', 'ciLowerLimit': '0.457', 'ciUpperLimit': '3.261', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.708', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'from baseline to week 16', 'description': 'Changes in iron parameters - serum iron - from baseline to week 16', 'unitOfMeasure': 'umol/l', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT OC'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '86', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'OG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 52', 'description': 'Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'safety population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'FG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}], 'periods': [{'title': 'Double Blind Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '90'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '17'}]}]}, {'title': 'Open Label Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '67'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Oral Ferric Maltol', 'description': '30mg capsules BID\n\nFerric maltol'}, {'id': 'BG001', 'title': 'Oral Placebo', 'description': 'Matching placebo capsules BID\n\nPlacebo'}, {'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': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '114', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'spread': '12.43', 'groupId': 'BG000'}, {'value': '65.2', 'spread': '12.79', 'groupId': 'BG001'}, {'value': '67.4', 'spread': '12.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '78', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', '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': '23', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '123', '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': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-12', 'size': 514133, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-04-02T07:47', 'hasProtocol': True}]}}, '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': 167}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2018-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-05', 'studyFirstSubmitDate': '2016-08-30', 'resultsFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2020-11-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-21', 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hb Concentration From Baseline to Week 16', 'timeFrame': '16 weeks', 'description': 'Change in hemoglobin concentration from baseline to Week 16.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects That Achieve an Increase in Hb Concentration of ≥1 g/dL at Week 16', 'timeFrame': '16 weeks', 'description': 'Number of subjects that achieve an increase in Hemoglobin concentration of ≥1 g/dL at Week 16'}, {'measure': 'Number of Subjects That Achieve a Hb Concentration of ≥11 g/dL at Week 16', 'timeFrame': '16 weeks', 'description': 'Number of subjects that achieve a Hemoglobin concentration of ≥11 g/dL at week 16'}, {'measure': 'Change in Hb Concentration From Baseline to Week 8', 'timeFrame': '8 weeks', 'description': 'Change in Hemoglobin concentration from baseline to Week 8'}, {'measure': 'Number of Subjects That Achieve an Increase in Hb Concentration of ≥2 g/dL at Week 16', 'timeFrame': '16 weeks', 'description': 'Number of subjects that achieve an increase in Hemoglobin concentration of ≥2 g/dL at Week 16'}, {'measure': 'Changes in Ferritin From Baseline to Week 16', 'timeFrame': 'baseline to week 16', 'description': 'Changes in iron parameter - ferritin - from baseline to week 16'}, {'measure': 'Number of Participants With (TEAEs)', 'timeFrame': 'Week 16', 'description': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs)'}, {'measure': 'Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Week 16', 'description': 'Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the double blind phase'}, {'measure': 'Changes in TSAT From Baseline to Week 16', 'timeFrame': 'baseline to week 16', 'description': 'Changes in iron parameters - TSAT - from baseline to week 16'}, {'measure': 'Changes in Iron Parameter From Baseline to Week 16', 'timeFrame': 'from baseline to week 16', 'description': 'Changes in iron parameters - serum iron - from baseline to week 16'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Week 52', 'description': 'Number of Participants with Treatment-Emergent Adverse Events (TEAEs) during the open label phase'}, {'measure': 'Number of Participants With Treatment-Emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'Week 52', 'description': 'Number of Participants with Treatment-Emergent Serious Adverse Events (TESAEs) during the open label phase'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Insufficiency, Chronic', 'Iron-Deficiency Anemia']}, 'referencesModule': {'references': [{'pmid': '34029682', 'type': 'DERIVED', 'citation': 'Pergola PE, Kopyt NP. Oral Ferric Maltol for the Treatment of Iron-Deficiency Anemia in Patients With CKD: A Randomized Trial and Open-Label Extension. Am J Kidney Dis. 2021 Dec;78(6):846-856.e1. doi: 10.1053/j.ajkd.2021.03.020. Epub 2021 May 23.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of oral ferric maltol compared with placebo in the treatment of IDA in subjects with CKD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Ability to understand the information given in the Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved information sheet and consent form. Must sign and date the informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations prior to any study mandated procedure.\n2. Willing and able to comply with study requirements.\n3. Age ≥ 18 years at the time of informed consent.\n4. A current diagnosis of CKD with an estimated glomerular filtration rate (eGFR) of \\<60 mL/min/1.73m2 and ≥15 mL/min/1.73m2, as calculated using the abbreviated version of the Modified Diet in Renal Disease equation (MDRD) assessed via screening laboratory results.\n5. Iron deficiency anemia defined by the following criteria assessed via screening laboratory results:\n\n 1. Hb \\<11.0g/dL and ≥8.0g/dL\n 2. AND ferritin \\<250ng/mL with a Transferrin saturation (TSAT) \\<25% OR ferritin \\<500ng/mL with a TSAT of \\<15%\n6. Female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit. Reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), complete sexual abstinence, a vasectomized partner and oral contraceptive medications. Female subjects who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or postmenopausal (defined as no menstrual period within 1 year of screening) are also allowed to participate.\n\nExclusion Criteria:\n\n1. Anemia due to any cause other than iron deficiency, including, but not limited to:\n\n 1. Untreated or untreatable severe malabsorption syndrome.\n 2. Myelosuppression use (permitted if taken at a stable dose and frequency for at least 12 weeks prior to randomization and are expected to stay stable throughout the double-blind treatment period so long as there is no clinical evidence of the myelosuppression contributing to the subject's anemia).\n2. Administration with any of the following prior to randomization:\n\n 1. IV iron injection within the previous 4 weeks or administration of intramuscular or depot iron preparation within the previous 12 weeks.\n 2. Single agent oral iron supplementation, taken specifically to treat anemia (e.g. ferrous sulfate, fumarate and gluconate) within the previous 2 weeks. Multivitamins are permitted.\n 3. Use if ferric citrate and sucroferric oxyhydroxide within the previous 1 week.\n 4. ESAs within the previous 4 weeks\n 5. Blood transfusion or donation within the previous 12 weeks.\n 6. Dimercaprol or cloramphenicol within the previous 7 days.\n 7. Current use of methyldopa.\n3. Currently receiving dialysis or initiation of dialysis is considered likely during the study.\n4. Renal transplant within 12 months prior to randomization or is considered likely during the study.\n5. Known hypersensitivity or allergy to the active substance or excipients of ferric maltol or placebo capsules.\n6. Contraindication for treatment with iron preparations, e.g. hemochromatosis, chronic hemolytic disease, sideroblastic anemia, thalassemia, or lead intoxication induced anemia.\n7. Impaired liver function as indicated by alanine aminotransferase (ALT) or aspartate transaminase (AST) \\> 3 times the upper limit of normal as assessed via screening laboratory results.\n8. Clinically significant vitamin B12 or folic acid deficiency as determined by the screening laboratory results (retest following at least 2 weeks of starting treatment with vitamin B12 or folate replacement is permitted).\n9. Pregnant or breast feeding.\n10. Concomitant medical conditions with significant active bleeding likely to initiate or prolong anemia; for example coagulation disorders or recurrent GI bleeding.\n11. Scheduled or expected major surgery during the course of the study. (Minor surgeries not associated with significant blood loss, in the Investigator's judgement, are permitted e.g. surgery related to fistulae or vascular access, minor dental extractions, incision and drainage of abscess or simple excisions).\n12. Participation in any other interventional clinical study within 30 days prior to screening.\n13. Cardiovascular, liver, renal, hematologic, psychiatric, neurologic, gastrointestinal, immunologic, endocrine, metabolic, or central nervous system disease that, in the opinion of the Investigator, may adversely affect the safety of the subject and/or efficacy of the study drug or severely limit the lifespan of the subject.\n14. Any other unspecified reason that, in the opinion of the Investigator or the Sponsor make the subject unsuitable for enrolment."}, 'identificationModule': {'nctId': 'NCT02968368', 'acronym': 'AEGIS-CKD', 'briefTitle': 'Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shield Therapeutics'}, 'officialTitle': 'A Phase 3, Randomized, Placebo Controlled, Prospective, Multicenter Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'ST10-01-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral ferric maltol', 'description': '30mg capsules BID', 'interventionNames': ['Drug: Ferric maltol']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Oral placebo', 'description': 'Matching placebo capsules BID', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ferric maltol', 'type': 'DRUG', 'otherNames': ['Feraccru'], 'armGroupLabels': ['Oral ferric maltol']}, {'name': 'Placebo', 'type': 'OTHER', 'armGroupLabels': ['Oral placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'city': 'Prescott', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 34.54002, 'lon': -112.4685}}, {'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 32.76783, 'lon': -117.02308}}, {'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'city': 'Roseville', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.75212, 'lon': -121.28801}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Coral Springs', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.27119, 'lon': -80.2706}}, {'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'city': 'Lauderdale Lakes', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 26.16647, 'lon': -80.20838}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Macon', 'state': 'Georgia', 'country': 'United States', 'geoPoint': {'lat': 32.84069, 'lon': -83.6324}}, {'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'city': 'Pontiac', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.63892, 'lon': -83.29105}}, {'city': 'Roseville', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.49726, 'lon': -82.93714}}, {'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'city': 'Knoxville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 35.96064, 'lon': -83.92074}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Hampton', 'state': 'Virginia', 'country': 'United States', 'geoPoint': {'lat': 37.02987, 'lon': -76.34522}}], 'overallOfficials': [{'name': 'Mark Sampson, MBChB', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Shield Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shield Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}