Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-27 @ 6:23 PM
Study NCT ID:
NCT02731534
Status:
COMPLETED
Last Update Posted:
2018-03-06
First Post:
2016-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}], 'ancestors': [{'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': 'D000077605', 'term': 'Ferric Oxide, Saccharated'}], 'ancestors': [{'id': 'D005290', 'term': 'Ferric Compounds'}, {'id': 'D058085', 'term': 'Iron Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D005937', 'term': 'Glucaric Acid'}, {'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-04', 'studyFirstSubmitDate': '2016-04-03', 'studyFirstSubmitQcDate': '2016-04-03', 'lastUpdatePostDateStruct': {'date': '2018-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum change in Hb value', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in Hb value', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of responders', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of subjects with normalization in Hb value', 'timeFrame': '12 weeks'}, {'measure': 'Proportion of cumulative dosage', 'timeFrame': '12 weeks'}, {'measure': 'Dosing period and the number of doses', 'timeFrame': '12 weeks'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': '12 weeks'}, {'measure': 'Incidence of Adverse Drug Reactions', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Iron Deficiency Anemia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm the non-inferiority of Z-213 compared to Saccharated Ferric Oxide using the maximum change in Hb from baseline over 12 weeks in patients with Iron-deficiency Anemia (IDA)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with iron deficiency anemia\n\nExclusion Criteria:\n\n* Patients with anemia caused by conditions other than iron deficiency\n* Patients with abnormal laboratory test values at screening for Serum phosphorus, Aspartate aminotransferase, Alanine aminotransferase\n* Patients with liver, kidney or circulatory system disease\n* Patients with a history or present illness that is a malignant tumor or autoimmune disease\n* Patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening\n* Patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening'}, 'identificationModule': {'nctId': 'NCT02731534', 'briefTitle': 'Efficacy Study of Intravenous Iron Preparation to Iron Deficiency Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Zeria Pharmaceutical'}, 'officialTitle': 'Phase III Study of Z-213 in Subjects With Iron-deficiency Anemia', 'orgStudyIdInfo': {'id': 'Z213-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Z-213', 'interventionNames': ['Drug: Z-213']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Saccharated Ferric Oxide', 'interventionNames': ['Drug: Saccharated Ferric Oxide']}], 'interventions': [{'name': 'Z-213', 'type': 'DRUG', 'description': "The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)", 'armGroupLabels': ['Z-213']}, {'name': 'Saccharated Ferric Oxide', 'type': 'DRUG', 'description': "The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week", 'armGroupLabels': ['Saccharated Ferric Oxide']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zeria Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}