Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03508466

Enrollment

Registered

2018-04-25

Start date

2017-10-01

Completion date

2019-12-31

Last updated

2020-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iron-deficiency

Keywords

hypersensitivity

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.

Interventions

BEHAVIORALhypersensitivity reaction

Previous hypersensitivity reaction

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Group 1) * 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

Design outcomes

Primary

Measure	Time frame	Description
Complement activation	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).

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026