NCT03508466

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 25, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

2.2 years

First QC Date

April 16, 2018

Last Update Submit

February 24, 2020

Conditions

Iron-deficiency

Keywords

hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Group 1

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

Behavioral: 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

Group 4

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

Interventions

hypersensitivity reactionBEHAVIORAL

Previous hypersensitivity reaction

Group 1Group 3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

participants with a previous hypersensitivity reaction to an iron nanomedicine application and participants without a hypersensitivity reaction to a previous iron nanomedicine application

You may qualify if:

  • 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

You may not qualify if:

  • Group 1)-4) • Autoimmune disorder or immune deficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Anemia, Iron-DeficiencyHypersensitivity

Interventions

Sensitivity and Specificity

Condition Hierarchy (Ancestors)

Anemia, HypochromicAnemiaHematologic DiseasesHemic and Lymphatic DiseasesIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesStatistics as TopicMathematical ConceptsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Esther H Steveling-Klein, Dr., MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2018

First Posted

April 25, 2018

Study Start

October 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Locations

CH(1)