Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| sp18Steveling | Other Identifier | CTU |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hypersensitivity reaction | Behavioral | Previous hypersensitivity reaction |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:Group 1)
Exclusion Criteria:
Not provided
Not provided
participants with a previous hypersensitivity reaction to an iron nanomedicine application and participants without a hypersensitivity reaction to a previous iron nanomedicine application
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Esther H Steveling-Klein, Dr., MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Basel | 4031 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D012680 | Sensitivity and Specificity |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D013223 | Statistics as Topic |
Not provided
Not provided
Not provided
Not provided
Not provided
| D000090463 |
| Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D007154 | Immune System Diseases |
| D055641 | Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |