Iron-deficiencyNCT03508466
Mechanism of Hypersensitivity Reactions to Iron Nanomedicines
An observational study of Iron-deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- hypersensitivity reaction
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Group 1)-4) • Autoimmune disorder or immune deficiency
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Iron-deficiency
- Being tested
- hypersensitivity reaction
- Keywords
- hypersensitivity
- Medical subject headings
- Anemia, Iron-Deficiency, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypersensitivity reactionBehavioural
Previous hypersensitivity reaction
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | adult participants from 18-65 years of age previous hypersensitivity reaction grades I-IV to intravenous ferric carboxymaltose (Ferinject) Receives: 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) Receives: Behavioral: hypersensitivity reaction | |
| Group 4 | adult participants from 18-65 years of age previous intravenous iron sucrose (Venofer) and no hypersensitivity reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start1 Oct 2017
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther H Steveling-Klein, Dr., MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508466
- Sponsor's protocol ID
- 2017-01606
- Other IDs
- sp18Steveling, 2017
- Status last verified
- Feb 2020
- First submitted
- 16 Apr 2018
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03508466
- Acronym / sponsor ID
- 2017-01606
- Conditions
- Iron-deficiency
- Keywords
- hypersensitivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Behavioral: hypersensitivity reactionadult 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 | – | Behavioral: hypersensitivity reactionadult 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Group 1)-4) • Autoimmune disorder or immune deficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypersensitivity reactionPrevious hypersensitivity reaction | Behavioural | Group 1, Group 3 |
Primary outcome
Complement activation
Time frame: 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
Related trials for Iron-deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life
Heart Failure With Preserved Ejection Fraction, Iron Deficiencies
Recruiting
Iron Absorption From a Nutritional Iron Supplement
Iron Absorption, Iron Deficiencies
RecruitingPhase 4
The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Heart Failure and Iron Deficiency
Heart Failure, Iron Deficiency
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esther H Steveling-Klein, Dr., MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron-deficiency, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complement activation (time frame: At baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.