Phase 3
N=634
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01114217 ↗Enrolled (actual)
634
Serious AEs
6.5%
Results posted
Jun 2018
Primary outcome: Primary: Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol — 2.6 g/dL — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ferumoxytol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AMAG Pharmaceuticals, Inc.
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol |
2.6 | <0.0001 sig |
| SECONDARY Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course |
2.6; 1.5; 1.1 | — |
| SECONDARY Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5 |
78.8; 43.9; 37.7 | — |
| SECONDARY Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol |
38.4; 57.0; 40.6 | — |
| SECONDARY Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol |
12.8; 11.7; 7.5 | — |
| SECONDARY Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol |
6.9; 4.1; 1.5 | — |
| SECONDARY Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline |
27.8; 30.6; 30.7 | — |
Summary
To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).
Eligibility Criteria
Key Inclusion Criteria include:
- Participants who completed participation in study AMAG-FER-IDA-301 [NCT01114139]
- Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study
Key Exclusion Criteria include:
- Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test
Data sourced from ClinicalTrials.gov (NCT01114217). 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.