Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
Study NCT ID:
NCT00704028
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2008-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000740', 'term': 'Anemia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522335', 'term': 'ferric carboxymaltose'}, {'id': 'D007505', 'term': 'Iron-Dextran Complex'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003911', 'term': 'Dextrans'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mfalone@luitpold.com', 'phone': '610-650-4200', 'title': 'Mark A. Falone, MD', 'organization': 'Luitpold Pharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.', 'otherNumAtRisk': 82, 'otherNumAffected': 45, 'seriousNumAtRisk': 82, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Iron Dextran', 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.', 'otherNumAtRisk': 78, 'otherNumAffected': 54, 'seriousNumAtRisk': 78, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Urticaria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Colon cancer recurrent', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vascular pseudoaneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 82, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 78, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '78', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.'}, {'id': 'OG001', 'title': 'Iron Dextran', 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.'}, {'id': 'FG001', 'title': 'Iron Dextran', 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '82'}, {'comment': 'A subject randomized to iron dextran never received study drug and was d/c due to subject request.', 'groupId': 'FG001', 'numSubjects': '78'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '21'}]}]}], 'recruitmentDetails': 'Hospitals and medical clinics', 'preAssignmentDetails': 'One subject randomized to iron dextran never received study drug and was discontinued due to subject request.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ferric Carboxymaltose (FCM)', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.'}, {'id': 'BG001', 'title': 'Iron Dextran', 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.'}, {'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': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.2', 'spread': '14.64', 'groupId': 'BG000'}, {'value': '48.2', 'spread': '17.10', 'groupId': 'BG001'}, {'value': '47.2', 'spread': '15.84', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '73', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '160', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-22', 'studyFirstSubmitDate': '2008-06-20', 'resultsFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2008-06-23', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-09-16', 'studyFirstPostDateStruct': {'date': '2008-06-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-11-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)", 'timeFrame': 'Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Anemia']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects ≥18 years of age and able to give informed consent\n* Iron deficiency is the primary etiology of anemia\n* History of intolerance or an unsatisfactory response to oral iron\n* Screening Visit central laboratory Hgb ≤11 g/dL\n* Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%\n\nExclusion Criteria:\n\n* Previous participation in a FCM trial\n* Known hypersensitivity reaction to FCM or iron dextran\n* Requires dialysis for treatment of chronic kidney disease\n* Current anemia not attributed to iron deficiency\n* Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase\n* Anticipated need for surgery during the 30 day period prior to screening or during the study period\n* AST or ALT greater than 1.5 times the upper limit of normal\n* Received an investigational drug within 30 days of screening\n* Women who are breastfeeding\n* Pregnant or sexually-active females who are not willing to use an effective form of birth control'}, 'identificationModule': {'nctId': 'NCT00704028', 'briefTitle': 'Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'American Regent, Inc.'}, 'officialTitle': 'A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia', 'orgStudyIdInfo': {'id': '1VIT08020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ferric Carboxymaltose (FCM)', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.', 'interventionNames': ['Drug: Ferric Carboxymaltose']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Iron Dextran', 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.', 'interventionNames': ['Drug: Iron Dextran']}], 'interventions': [{'name': 'Ferric Carboxymaltose', 'type': 'DRUG', 'description': '15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.', 'armGroupLabels': ['Ferric Carboxymaltose (FCM)']}, {'name': 'Iron Dextran', 'type': 'DRUG', 'otherNames': ['Dexferrum, INFeD'], 'description': 'As determined by the investigator to a maximum cumulative dose of 2,250 mg.', 'armGroupLabels': ['Iron Dextran']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19403', 'city': 'Norristown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Luitpold Pharmaceuticals', 'geoPoint': {'lat': 40.1215, 'lon': -75.3399}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American Regent, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}