18 and older, any sex, with Iron Deficiency Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe HypotensionPrimary· Day 1 (after first dosing) through Week 5
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.
Moderate hypersensitivity reaction
Group
Value
95% CI
Ferumoxytol
3
Ferric Carboxymaltose (FCM)
6
Severe hypersensitivity reaction
Group
Value
95% CI
Ferumoxytol
1
Ferric Carboxymaltose (FCM)
0
Anaphylaxis
Group
Value
95% CI
Ferumoxytol
0
Ferric Carboxymaltose (FCM)
0
Moderate hypotension
Group
Value
95% CI
Ferumoxytol
2
Ferric Carboxymaltose (FCM)
1
Severe hypotension
Group
Value
95% CI
Ferumoxytol
0
Ferric Carboxymaltose (FCM)
0
Any TE moderate to severe hypersensitivity rxn
Group
Value
95% CI
Ferumoxytol
6
Ferric Carboxymaltose (FCM)
7
Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And DeathSecondary· Day 1 (after first dosing) through Week 5
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.
Moderate hypersensitivity reaction
Group
Value
95% CI
Ferumoxytol
3
Ferric Carboxymaltose (FCM)
6
Severe hypersensitivity reaction
Group
Value
95% CI
Ferumoxytol
1
Ferric Carboxymaltose (FCM)
0
Anaphylaxis
Group
Value
95% CI
Ferumoxytol
0
Ferric Carboxymaltose (FCM)
0
Serious cardiovascular event
Group
Value
95% CI
Ferumoxytol
6
Ferric Carboxymaltose (FCM)
13
Death
Group
Value
95% CI
Ferumoxytol
4
Ferric Carboxymaltose (FCM)
2
Any moderate to severe hypersensitivity rxn
Group
Value
95% CI
Ferumoxytol
13
Ferric Carboxymaltose (FCM)
20
Mean Change In Hemoglobin From Baseline To Week 5Secondary· Baseline (Day 1), 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.
Group
Value
95% CI
Ferumoxytol
1.38
± 1.351
Ferric Carboxymaltose (FCM)
1.63
± 1.535
Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5Secondary· Baseline (Day 1), 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.
Group
Value
95% CI
Ferumoxytol
1.35
± 1.353
Ferric Carboxymaltose (FCM)
1.10
± 1.050
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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Other recruiting trials for Iron Deficiency Anemia
Currently open trials in the same condition.
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· recruiting
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· recruiting
NCT05929729 — Iron Deficiency Anemia (IDA) and the Brain
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· recruiting
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· NA
· active not recruiting
Other AMAG Pharmaceuticals, Inc. trials
Trials by the same sponsor.
NCT04593784 — Study of Ciraparantag for Reversal of Anticoagulation Induced by Edoxaban, Apixaban or Rivaroxaban in Healthy Adults
· Phase 2
· terminated
NCT03973047 — Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alon
· Phase 1
· completed
NCT03619850 — A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatmen
· Phase 3
· recruiting
NCT03008616 — Study of the Efficacy and Safety of AMAG-423 (Digoxin Immune Fab) in Antepartum Subjects With Severe Preeclampsia
· Phase 2, PHASE3
· terminated
NCT02937766 — Study Assessing Injection Pain of Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL) When Administered Via Subc
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc.
Last refreshed: 25 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02694978.