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Mechanism of Hypersensitivity Reactions to Iron Nanomedicines

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Completed
CT.gov ID
NCT03508466
Collaborator
(none)
42
Enrollment
1
Location
27
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: hypersensitivity reaction

Study Design

Study Type:
Observational
Actual Enrollment :
42 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Dec 31, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Group 1

adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject)

Behavioral: hypersensitivity reaction
Previous hypersensitivity reaction
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)

Behavioral: hypersensitivity reaction
Previous hypersensitivity reaction
Group 4

adult participants from 18-65 years of age previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Basel Switzerland 4031

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Esther H Steveling-Klein, Dr., MD, University Hospital, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT03508466
Other Study ID Numbers:
  • 2017-01606
  • sp18Steveling
First Posted:
Apr 25, 2018
Last Update Posted:
Feb 25, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Basel, Switzerland
hypersensitivity
Additional relevant MeSH terms:
Hypersensitivity

Study Results

No Results Posted as of Feb 25, 2020