Comparison of Oral Ferrous Sulfate to Intravenous Ferumoxytol in Antepartum Iron Deficiency Anemia

NCT04253626 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: 54788K12HD103084
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluate the extent to which treatment of iron deficiency anemia beyond 24-34 weeks' gestation of pregnancy with intravenous iron increases hemoglobin compared to oral iron. The investigators will test the hypothesis that pregnant women who are anemic in the second and third trimester are more likely to significantly increase their hemoglobin with intravenous iron as opposed to the usual standard of care, oral iron.

Conditions

Pregnancy Related; Anemia, Iron Deficiency

Outcome Measures

Primary Outcomes (1)

• Median Change in Hemoglobin Value Before and After Intervention

  Hemoglobin is measured as g/dL at enrollment and after the study intervention

  From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Secondary Outcomes (7)

• Number of Participants Who Discontinued Treatment

  From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

• Number of Participants With Serious Adverse Events Associated With Treatment

  From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

• Number of Participants Who Need Blood Transfusion Postpartum

  From enrollment to delivery or birth admission (average approximately 8 to 12 weeks)

• Change in Short Form (SF-)36 General Health Symptom Score

  From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

• Change in Short Form (SF-)36 Physical Functioning Score

  From enrollment to four weeks post-enrollment (may have been up to 6 weeks post-enrollment)

Study Arms (2)

Intravenous iron

EXPERIMENTAL

Participants will receive 510mg intravenous iron ferumoxytol, with a maximum of 2 doses based on the baseline hemoglobin level. The ferumoxytol is administered as an infusion for approximately 15 - 30 minutes.

Drug: Ferumoxytol Injection [Feraheme]

Oral iron

ACTIVE COMPARATOR

Participants will be prescribed 1-2 ferrous sulfate 325mg tablets by mouth (based on severity of anemia) until delivery. For standardization, the dosage is as follows based on severity: one ferrous sulfate tablet for women with baseline hemoglobin 9-11, and two ferrous sulfate tablets for hemoglobin \< 9.

Drug: Ferrous Sulfate

Interventions

Ferumoxytol Injection [Feraheme] DRUG

510mg intravenous ferumoxytol

Intravenous iron

Ferrous Sulfate DRUG

325mg oral ferrous sulfate

Oral iron

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women 18 years old and above
• Hemoglobin \< 11 g/dL, serum ferritin \< 30 ug/dL and or transferrin saturation (TSAT) \< 20%
• Between 24-34 weeks' pregnancy
• Singleton pregnancy
• Receiving prenatal care at Stanford/LPCH OB clinic and planning to deliver at LPCH
• Hemodynamically stable

You may not qualify if:

• Patients unable to give informed consent
• Known allergy/hypersensitivity to IV iron
• Inflammatory Bowel Disease or history of gastric bypass surgery
• Dialysis-dependent Chronic Kidney Disease/ ESRD
• Known Hemoglobinopathies such as sickle cell disease, beta-thalassemia, alpha thalassemia
• Folate/Vitamin B12 deficiency
• Known malignancy
• Medication allergy to Tylenol (acetaminophen)
• Hemoglobin above 12 or less than 7 g/dL
• Patients with complex past medical histories which may include history of multiple medication allergies (greater than 2 allergies), connective tissue disorder, etc.
• Diagnosis of placenta previa

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine/Lucile Packard Childrens Hospital

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide; ferrous sulfate

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Deirdre J. Lyell, MD
• Organization: Stanford University

dlyell@stanford.edu

(650) 498-4069

Study Officials

• Deirdre Lyell

  Stanford University

  PRINCIPAL INVESTIGATOR

• Irogue Igbinosa, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Obstetrics & Gynecology

Study Record Dates

• First Submitted: January 31, 2020
• First Posted: February 5, 2020
• Study Start: January 21, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)