18 and older, any sex, with Iron Deficiency or 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.
Mean Change In Hemoglobin From Baseline (Day 1) To Week 5Primary· Baseline (Day 1), Week 5
The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:
Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)
The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were perfo
With LOCF Imputation
Group
Value
95% CI
Ferumoxytol
0.84
± 0.14
Iron Sucrose
0.74
± 0.14
Without Imputation (Sensitivity Analysis)
Group
Value
95% CI
Ferumoxytol
0.89
± 0.15
Iron Sucrose
0.80
± 0.15
Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5Primary· Baseline (Day 1) and up to Week 5
The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).
Week 2
Group
Value
95% CI
Ferumoxytol
20
Iron Sucrose
11
Week 3
Group
Value
95% CI
Ferumoxytol
32
Iron Sucrose
20
Week 4
Group
Value
95% CI
Ferumoxytol
37
Iron Sucrose
31
Week 5
Group
Value
95% CI
Ferumoxytol
40
Iron Sucrose
34
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.
Ferumoxytol
Serious: 7/80 (9%)
Deaths: —
Iron Sucrose
Serious: 6/82 (7%)
Deaths: —
Serious adverse events (19 terms)
Reaction
System
Ferumoxytol
Iron Sucrose
Abscess limb
Infections and infestations
—
—
Arteriovenous graft site infection
Infections and infestations
—
—
Cellulitis
Infections and infestations
—
—
Gastroenteritis
Infections and infestations
—
—
Pneumonia
Infections and infestations
—
—
Urinary tract infection
Infections and infestations
—
—
Anastomotic haemorrhage
Injury, poisoning and procedural complications
—
—
Seroma
Injury, poisoning and procedural complications
—
—
Vascular graft thrombosis
Injury, poisoning and procedural complications
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Peritoneal adhesions
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Acute prerenal failure
Renal and urinary disorders
—
—
Renal failure chronic
Renal and urinary disorders
—
—
Deep vein thrombosis
Vascular disorders
—
—
Hypotension
Vascular disorders
—
—
Anaphylactic reaction
Immune system disorders
—
—
Hyperkalaemia
Metabolism and nutrition disorders
—
—
Lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07461948 — Advanced Imaging Techniques for Evaluating the Tumor Immune Microenvironment in Glioblastoma Patients
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· recruiting
NCT06483061 — Enhanced MRI Imaging in Healthy Participants and Participants With Epilepsy
· Phase 2
· recruiting
NCT05811377 — Phenotyping Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) by Intravesical Contrast Enhanced - Magnetic Resonance
· EARLY_PHASE1
· completed
NCT04278651 — Early Antenatal Support for Iron Deficiency Anemia
· Phase 4
· recruiting
NCT03657433 — Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
· Phase 3
· completed
Other recruiting trials for Iron Deficiency
Currently open trials in the same condition.
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· recruiting
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· recruiting
NCT07053475 — IRONICA: IRON Repletion In Heart Failure - A Comparison of Oral and IV Approaches
· Phase 4
· recruiting
NCT06879080 — Maternal Iron Deficiency and Childhood Health
· recruiting
NCT06427343 — The Effects of Low-Dose Versus High-Dose Intravenous IRON Therapy With Ferric DerisomaltOSE in Patients With Chronic Hea
· Phase 4
· 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/NCT01052779.