Phase 3
Completed N=605
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Source: ClinicalTrials.gov NCT01114204 ↗Enrolled (actual)
605
Serious AEs
3.6%
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 — 291; 117; 327; 145 Participants — p=0.2833
◆ Published Evidence
Established
78citations · ~7 / year
A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy.
Summary
The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
Linked Publications (2)
-
A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy.
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Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia.
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 |
291; 117; 327; 145; 341; 162 | 0.2833 |
| SECONDARY Mean Change In Hemoglobin From Baseline To Week 5 |
2.9; 2.7 | — |
| SECONDARY Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5 |
123; 33; 210; 67; 271; 96 | — |
| SECONDARY Mean Change In TSAT From Baseline To Week 5 |
15.7; 11.9 | — |
| SECONDARY Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5 |
13.1; 12.4 | — |
| SECONDARY Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline |
23.1; 25.2 | — |
Eligibility Criteria
Key Inclusion Criteria include:
- Males and females ≥18 years of age
- Participants with IDA defined as having:
- Hemoglobin 600 nanogram/mL
Data sourced from ClinicalTrials.gov (NCT01114204) 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.