Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-01-02 @ 9:18 AM
Study NCT ID:
NCT03508466
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2018-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanism of Hypersensitivity Reactions to Iron Nanomedicines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018798', 'term': 'Anemia, Iron-Deficiency'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012680', 'term': 'Sensitivity and Specificity'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013223', 'term': 'Statistics as Topic'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-24', 'studyFirstSubmitDate': '2018-04-16', 'studyFirstSubmitQcDate': '2018-04-16', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complement activation', 'timeFrame': 'At baseline', 'description': 'The primary outcome, complement activation, will be measured by the respective concentrations of the complement compounds sC5b9, C4d, C3a and C5a (ng/ml), and CP, LP and AP (%) 30 minutes after titration of two concentrations (100 ng/ml and 500 ng/ml) of Ferinject and Venofer into serum probes. That is for each subject, four serum probes will be analysed (100 ng/ml Ferinject, 500 ng/ml Ferinject, 100 ng/ml Venofer and 500 ng/ml Venofer).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hypersensitivity'], 'conditions': ['Iron-deficiency']}, 'descriptionModule': {'briefSummary': 'Iron deficiency is common and when oral treatment is not sufficient intravenous application is indicated. Hypersensitivity to intravenous iron nanomedicines is rare but does occur and little is known about the underlying mechanism but complement activation has been suggested.\n\nThis is a purely exploratory study as it is not yet known whether in vitro complement activation can be stimulated by titration with iron preparations. These data will provide first empirical evidence of whether and to what extent complement activation occurs in this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'participants with a previous hypersensitivity reaction to an iron nanomedicine application and participants without a hypersensitivity reaction to a previous iron nanomedicine application', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Group 1)\n\n* adult participants from 18-65 years of age\n* previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) Group 2)\n* adult participants from 18-65 years of age\n* previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction Group 3)\n* adult participants from 18-65 years of age\n* previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer) Group 4)\n* adult participants from 18-65 years of age\n* previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction\n\nExclusion Criteria:\n\n* Group 1)-4) • Autoimmune disorder or immune deficiency'}, 'identificationModule': {'nctId': 'NCT03508466', 'briefTitle': 'Mechanism of Hypersensitivity Reactions to Iron Nanomedicines', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Investigation of the Underlying Mechanism of Hypersensitivity Reactions to Intravenous Iron Nanomedicines in Patients With Previous Hypersensitivity Reaction Compared to Controls - a Cross-sectional Study', 'orgStudyIdInfo': {'id': '2017-01606'}, 'secondaryIdInfos': [{'id': 'sp18Steveling', 'type': 'OTHER', 'domain': 'CTU'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject)', 'interventionNames': ['Behavioral: hypersensitivity reaction']}, {'label': 'Group 2', 'description': 'adult participants from 18-65 years of age previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction'}, {'label': 'Group 3', 'description': 'adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer)', 'interventionNames': ['Behavioral: hypersensitivity reaction']}, {'label': 'Group 4', 'description': 'adult participants from 18-65 years of age previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction'}], 'interventions': [{'name': 'hypersensitivity reaction', 'type': 'BEHAVIORAL', 'description': 'Previous hypersensitivity reaction', 'armGroupLabels': ['Group 1', 'Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Esther H Steveling-Klein, Dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}