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CompletedNCT04359368Updated Apr 24, 2020

Characteristics of Patients With Hypersensitivity Reactions to Intravenous Iron Infusions

An observational study in Iron-deficiency and Hypersensitivity Reactions, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.

Sponsored by University Hospital, Basel, Switzerland · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
42
Ages
16 Years and older
Sex
All
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Study summary

This study aims to evaluate characteristics of patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer) including age, atopy status, previous allergic reactions, previous medical history, current medications and co-morbidities. Furthermore, symptoms on reaction such as severity grade of reaction will be evaluated.

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Conditions studied

  • Iron-deficiency
  • Hypersensitivity Reactions

Keywords

  • complement activation-related pseudoallergy (CARPA)
  • Hypersensitivity reactions (HSR)
  • iron-deficiency
  • non dextran iron preparations (NDIPs)
  • anemia
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In context

Anemia, Iron-Deficiency

644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.

This study's enrollment of 42 is below the median of 200 across 113 observational studies indexed under Anemia, Iron-Deficiency.

Browse Anemia, Iron-Deficiency studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Inclusion criteria

  • Participants from 16 years of age and older with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer).

Exclusion criteria

Exclusion Criteria:

  • No previous hypersensitivity reaction to iron preparations or reactions to oral iron preparations.
  • If a rejection to use patient data is documented in patient records, the patient will be excluded from analysis.
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
42 participants (actual)
Patient registry
No

Groups and cohorts

  • patients with hypersensitivity reactions to NDIPs

    Patients with previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) or to iron sucrose (Venofer)

    Other: collection of patient data

Interventions

  • Othercollection of patient data

    Data collection (history, clinical presentation, medication, complications, laboratory testing) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs.

06

What researchers measure

Primary outcomes

  1. previous medical history

    Data collection (medical history) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs

    Time frame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

  2. Family history

    Data collection (Family history) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs

    Time frame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

  3. assessment of hypersensitivity reactions

    assessment of hypersensitivity reactions (grade I-IV) to Ferinject or Venofer

    Time frame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

  4. preparation used

    which preparation was used for Treatment ( iron sucrose (Venofer) or ferric carboxymaltose (Ferinject)

    Time frame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

  5. co-medication

    which co-medication was used

    Time frame: Baseline; Patients with HSRs to NDIPs that were treated at the University Hospital Basel between the 16th of January 2018 and the 24th of October 2019

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Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04359368
Lead sponsor
University Hospital, Basel, Switzerland
Responsible party
Sponsor
First posted
Apr 24, 2020
Start date
Sep 1, 2019
Primary completion
Oct 31, 2019
Completion
Oct 31, 2019
Last update
Apr 24, 2020

Study contacts

Esther Steveling-Klein, Dr. med
principal investigator · Allergology, University Hospital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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