Phase 3
Completed N=812
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT01114139 ↗Enrolled (actual)
812
Serious AEs
2.7%
Results posted
Jun 2018
Primary outcomePrimary: Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 — 252; 5; 386; 7 Participants — p=<0.0001
◆ Published Evidence
Established
76citations · ~6 / year
Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron.
Summary
To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).
Linked Publications
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Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5 |
252; 5; 386; 7; 460; 8 | <0.0001 sig |
| SECONDARY Mean Change In Hemoglobin From Baseline To Week 5 |
2.6; 0.1 | — |
| SECONDARY Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 |
33; 3; 131; 5; 240; 5 | — |
| SECONDARY Mean Change In TSAT From Baseline To Week 5 |
11.4; 0.4 | — |
| SECONDARY Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5 |
11.7; 6.8 | — |
| SECONDARY Time To Hemoglobin Increase Of ≥2.0 g/dL Or A Hemoglobin Value Of ≥12.0 g/dL From Baseline |
23.5; 42.5 | — |
Eligibility Criteria
Key Inclusion Criteria include:
- Males and females ≥18 years of age
- Participants with IDA defined as having:
- Hemoglobin 600 nanograms/mL
Data sourced from ClinicalTrials.gov (NCT01114139) 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.