Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-08 @ 4:29 AM
Study NCT ID:
NCT03286205
Status:
WITHDRAWN
Last Update Posted:
2019-06-05
First Post:
2017-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.
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': 'C066317', 'term': 'ferryl iron'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'IP unavailable at site.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-03', 'studyFirstSubmitDate': '2017-09-14', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2019-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'superior dosing regimen exists for INfed', 'timeFrame': '3 years', 'description': 'shown by a 2gm/dl increase in HgB'}, {'measure': 'High Dose Effect', 'timeFrame': '3 years', 'description': 'INfed can be given at high dose without an increase in AE and/or SAEs frequency'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anemia, Iron Deficiency']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia.', 'detailedDescription': 'The purpose of this study is to establish which dosing schedule of INfed (Iron dextrose) is superior for the treatment of iron deficient anemia. The two dosing regimens under review are a low dose weekly or a larger dose given every three weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients over the age of 18 years old.\n2. Being treated by a Sutter Health Physician.\n3. Hemoglobin of \\< 10mg/dl for Men and Women\n4. Ferritin \\</= 10ng/ml\n5. Patients in whom oral administration is unsatisfactory or impossible.\n\nExclusion Criteria:\n\n1. Patients with a history of receiving iron or other hematinic in the preceding 3 months, oral iron is allowable.\n2. Anemia due to acute blood loss; menorrhagia is allowed.\n3. Patients with a current illness known to interact with iron status.\n4. Patients unwilling to consent to required blood draws.\n5. Patients who are viewed as unable to complete treatment, based on PI recommendation.'}, 'identificationModule': {'nctId': 'NCT03286205', 'briefTitle': 'A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Sutter Gould Medical Foundation'}, 'officialTitle': 'A Randomized Study to Compare the Dosing Schedule of INFeD in Anemic Patients.', 'orgStudyIdInfo': {'id': '001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Weekly Dosage', 'description': 'weekly dose of 100mg', 'interventionNames': ['Drug: IV iron']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3 week dosage', 'description': 'every 3 week dosage.', 'interventionNames': ['Drug: IV iron']}], 'interventions': [{'name': 'IV iron', 'type': 'DRUG', 'description': 'IV iron infusion based on weekly or every 3 week dosage.', 'armGroupLabels': ['3 week dosage', 'Weekly Dosage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95355', 'city': 'Modesto', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Gould Medical Foundation', 'geoPoint': {'lat': 37.6391, 'lon': -120.99688}}], 'overallOfficials': [{'name': 'David Adkins, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sutter Gould Medical Foundation', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Adkins', 'investigatorAffiliation': 'Sutter Gould Medical Foundation'}}}}