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
Sponsor study identifier
Secondary identifiers
OTHER · CTU
NIH
observational
42
1 country
1
Study Start
October 1, 2017
Actual (reported)Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 1, 2017
Actual (reported)April 16, 2018
Actual (reported)April 25, 2018
Actual (reported)December 31, 2019
Actual (reported)December 31, 2019
Actual (reported)Complement activation
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).
At baseline
adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject)
adult participants from 18-65 years of age previous intravenous ferric carboxymaltose (Ferinject) and no hypersensitivity reaction
adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer)
adult participants from 18-65 years of age previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction
Previous hypersensitivity reaction
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
participants with a previous hypersensitivity reaction to an iron nanomedicine application and participants without a hypersensitivity reaction to a previous iron nanomedicine application
University Hospital
Basel, 4031, Switzerland
Esther H Steveling-Klein, Dr., MD
University Hospital, Basel, Switzerland
42 participants (actual enrollment reported by the registry).
First Submitted
April 16, 2018
First Posted
April 25, 2018
Study Start
October 1, 2017
Actual (reported)Determination of a Dose-dependent Effect of GOS on Iron Absorption, and Addition of Vitamin C
Contact the study team to confirm eligibility.
Primary Completion
December 31, 2019
Actual (reported)Study Completion
December 31, 2019
Actual (reported)Last Updated
February 25, 2020
Record last verified: 2020-02
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Source: ClinicalTrials.gov.
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