A Phase 3 interventional study of Ferumoxytol and FCM in Iron Deficiency Anemia, sponsored by AMAG Pharmaceuticals, Inc.. Completed at 127 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by AMAG Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.
This study's enrollment of 2,014 is above the median of 94 across 1,291 interventional studies indexed under Anemia.
Browse Anemia studies →AMAG Pharmaceuticals, Inc. is the lead sponsor of 24 studies on the registry; 2 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria include:
Participants with IDA and in whom IV iron treatment is indicated and defined as:
Key Exclusion Criteria include:
Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter \[mL\]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
Drug: Ferumoxytol
Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
Drug: FCM
Also known as: Feraheme
Also known as: Injectafer, Ferinject
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a \>30% drop in systolic blood pressure from baseline or decrease of \>20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Day 1 (after first dosing) through Week 5
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Time frame: Day 1 (after first dosing) through Week 5
Mean Change In Hemoglobin From Baseline To Week 5
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Time frame: Baseline (Day 1), Week 5
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Time frame: Baseline (Day 1), Week 5
Participants with iron deficiency anemia (IDA), \<12.0 grams (g) per deciliter (dL) for females and \<14.0 g/dL for males within 60 days of dosing and transferrin saturation (TSAT) \<20% or Ferritin ≤100 nanograms (ng) per milliliter (mL) within 60 days of dosing and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used.
| Milestone | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Started | 1006 | 1008 |
| Received at least 1 dose of study drug | 997 | 1000 |
| Completed | 935 | 948 |
| Not completed | 71 | 60 |
| Withdrew: Adverse event | 10 | 9 |
| Withdrew: Withdrawal by subject | 22 | 19 |
| Withdrew: Lost to follow-up | 14 | 17 |
| Withdrew: Death | 4 | 1 |
| Withdrew: Other-decision of participant | 6 | 1 |
| Withdrew: Other-investigator's decision | 1 | 0 |
| Withdrew: Other-unable to be reached | 0 | 1 |
| Withdrew: Other-protocol noncompliant | 2 | 1 |
| Withdrew: Other-personal reasons | 3 | 3 |
| Withdrew: Other-withdrew prior to dosing | 9 | 8 |
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a \>30% drop in systolic blood pressure from baseline or decrease of \>20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Participants | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Moderate hypersensitivity reaction | 3 | 6 |
| Severe hypersensitivity reaction | 1 | 0 |
| Anaphylaxis | 0 | 0 |
| Moderate hypotension | 2 | 1 |
| Severe hypotension | 0 | 0 |
| Any TE moderate to severe hypersensitivity rxn | 6 | 7 |
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
| Participants | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Moderate hypersensitivity reaction | 3 | 6 |
| Severe hypersensitivity reaction | 1 | 0 |
| Anaphylaxis | 0 | 0 |
| Serious cardiovascular event | 6 | 13 |
| Death | 4 | 2 |
| Any moderate to severe hypersensitivity rxn | 13 | 20 |
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
| g/dL | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Mean Change In Hemoglobin From Baseline To Week 5 | 1.38 ± 1.351 | 1.63 ± 1.535 |
Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
| g/dL | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 | 1.35 ± 1.353 | 1.10 ± 1.050 |
Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ferumoxytol | — | 36/997 (3.6%) | 186/997 (18.7%) |
| Ferric Carboxymaltose (FCM) | — | 35/1,000 (3.5%) | 245/1,000 (24.5%) |
| Event | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| SyncopeNervous system disorders | 3/997 | 3/1000 |
| GastroenteritisInfections and infestations | 3/997 | 1/1000 |
| Cardiac failure congestiveCardiac disorders | 1/997 | 3/1000 |
| SeizureNervous system disorders | 2/997 | 0/1000 |
| PneumoniaInfections and infestations | 2/997 | 0/1000 |
| Haemorrhagic anaemiaBlood and lymphatic system disorders | 2/997 | 0/1000 |
| Acute kidney injuryRenal and urinary disorders | 2/997 | 0/1000 |
| Angina pectorisCardiac disorders | 0/997 | 2/1000 |
| Atrial fibrillationCardiac disorders | 0/997 | 2/1000 |
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 1/743 | 0/776 |
| Event | Ferumoxytol | Ferric Carboxymaltose (FCM) |
|---|---|---|
| HeadacheNervous system disorders | 60/997 | 82/1000 |
| NauseaGastrointestinal disorders | 35/997 | 60/1000 |
| DizzinessNervous system disorders | 25/997 | 40/1000 |
| FatigueGeneral disorders | 30/997 | 36/1000 |
| DiarrhoeaGastrointestinal disorders | 29/997 | 33/1000 |
| PyrexiaGeneral disorders | 7/997 | 22/1000 |
| Abdominal painGastrointestinal disorders | 17/997 | 21/1000 |
| Back painMusculoskeletal and connective tissue disorders | 19/997 | 16/1000 |
| HypophosphataemiaMetabolism and nutrition disorders | 0/997 | 18/1000 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 11/997 | 18/1000 |
The safety population included any randomized participant who received any amount of study drug. Treatment group was based on actual treatment.
| Age, Continuous(years) | Ferumoxytol | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Mean | 55.6 ± 17.30 | 54.8 ± 17.02 | 55.2 ± 17.16 |
| Sex: Female, Male(Participants) | Ferumoxytol | Ferric Carboxymaltose (FCM) | Total |
|---|---|---|---|
| Female | 743 | 776 | 1519 |
| Male | 254 | 224 | 478 |
Showing the first 100 of 127 sites across 7 countries.
Plan to share: No
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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AMAG Pharmaceuticals, Inc.