Phase 3
N=812
A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01114139 ↗Enrolled (actual)
812
Serious AEs
2.7%
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 — 252; 5; 386; 7 Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferumoxytol (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Primary completion
- Feb 2012
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 | — |
Summary
To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo 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 nanograms/mL
Data sourced from ClinicalTrials.gov (NCT01114139). 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.