Mechanism of Hypersensitivity Reactions to Iron Nanomedicines
NCT ID: NCT03508466
Last Updated: 2020-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
42 participants
OBSERVATIONAL
2017-10-01
2019-12-31
Brief Summary
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This 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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
CROSS_SECTIONAL
Study Groups
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Group 1
adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject)
hypersensitivity reaction
Previous hypersensitivity reaction
Group 2
adult participants from 18-65 years of age previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction
No interventions assigned to this group
Group 3
adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer)
hypersensitivity reaction
Previous hypersensitivity reaction
Group 4
adult participants from 18-65 years of age previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction
No interventions assigned to this group
Interventions
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hypersensitivity reaction
Previous hypersensitivity reaction
Eligibility Criteria
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Inclusion Criteria
* previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) Group 2)
* adult participants from 18-65 years of age
* previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction Group 3)
* adult participants from 18-65 years of age
* previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer) Group 4)
* adult participants from 18-65 years of age
* previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Esther H Steveling-Klein, Dr., MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital
Basel, , Switzerland
Countries
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Other Identifiers
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sp18Steveling
Identifier Type: OTHER
Identifier Source: secondary_id
2017-01606
Identifier Type: -
Identifier Source: org_study_id
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