Phase 3
Completed N=2,014
A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Source: ClinicalTrials.gov NCT02694978 ↗Enrolled (actual)
2,014
Serious AEs
3.6%
Results posted
Jun 2018
Primary outcomePrimary: Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension — 3; 6; 1; 0 Participants — p=0.0001
◆ Published Evidence
Highly cited
191citations · ~24 / year
Randomized trial of intravenous iron-induced hypophosphatemia.
Summary
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
Linked Publications
-
Randomized trial of intravenous iron-induced hypophosphatemia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension |
3; 6; 1; 0; 0; 0 | 0.0001 sig |
| SECONDARY Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death |
3; 6; 1; 0; 0; 0 | — |
| SECONDARY Mean Change In Hemoglobin From Baseline To Week 5 |
1.38; 1.63 | — |
| SECONDARY Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 |
1.35; 1.10 | — |
Eligibility Criteria
Key Inclusion Criteria include:
- Participants with IDA and in whom IV iron treatment is indicated and defined as:
- Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
- Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
- Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
- All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study
Key Exclusion Criteria include:
- Known hypersensitivity reaction to any component of ferumoxytol or FCM
- History of allergy to an IV iron
- History of multiple drug allergies
- Participants with dialysis-dependent chronic kidney disease
- Hemoglobin ≤7.0 g/dL
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Data sourced from ClinicalTrials.gov (NCT02694978) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.