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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Complement activation
Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult participants from 18-65 years of age
- •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
- •Group 1)-4) • Autoimmune disorder or immune deficiency
Outcomes
Primary Outcomes
Complement activation
Time Frame: At baseline
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).
Secondary Outcomes
No secondary outcomes reported