Phase 3
N=605
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01114204 ↗Enrolled (actual)
605
Serious AEs
3.6%
Results posted
Jun 2018
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferumoxytol (Drug); Iron Sucrose (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Primary completion
- Nov 2011
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 | — |
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).
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). 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.