Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

Completed

• Conditions: Iron-deficiency
• Interventions: Behavioral: hypersensitivity reaction

• Registration Number: NCT03508466
• Lead Sponsor: University Hospital, Basel, Switzerland

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-04-16
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	hypersensitivity reaction	adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject)
Group 3	hypersensitivity reaction	adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to iron sucrose (Venofer)

Primary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University Hospital; 🇨🇭 Basel, Switzerland