Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

Iron-deficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508466
• Other study ID #: 2017-01606
• Secondary ID: sp18Steveling
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Iron-deficiency

Intervention

Behavioral:
• hypersensitivity reaction
Previous hypersensitivity reaction

Locations

Country	Name	City	State
Switzerland	University Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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