IV vs Oral Iron Therapy for Anemia in Pregnancy

(EASI-A Trial)

Overseen By Rupsa C Boelig, MD

Age: 18+

Sex: Female

Trial Phase: Phase 4

Sponsor: Thomas Jefferson University

Disqualifiers: Sickle cell disease, Severe cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 90 days

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Ferrous Sulfate, Ferumoxytol, and Feraheme for treating anemia in pregnancy?

Research shows that intravenous ferumoxytol is more effective than oral ferrous sulfate for treating anemia in pregnancy. Additionally, intravenous iron treatments, like iron sucrose, have been found to be effective and safe compared to oral iron in pregnant women with iron deficiency anemia. ^{1 2 3 4 5}

Is IV iron therapy with ferumoxytol safe for humans?

Ferumoxytol, an IV iron therapy, is generally safe but can cause some side effects like allergic reactions (e.g., itching, rash, or wheezing) and low blood pressure. Serious allergic reactions were rare, occurring in 0.2% of cases, and low blood pressure was seen in 1.9% of patients. ^{1 6 7 8 9}

How does the drug Ferumoxytol differ from other treatments for anemia in pregnancy?

Ferumoxytol is unique because it is an intravenous (IV) iron treatment, which may provide faster and more effective results compared to oral iron supplements like ferrous sulfate, especially in cases of severe anemia during pregnancy. ^{1 4 7 9 10}

What is the purpose of this trial?

This is a randomized, controlled multi-site trial of iron therapy in pregnancy. The purpose of this research is to see if second trimester initiation of intravenous (IV) iron therapy is better than oral iron therapy for treatment of anemia in pregnancy by improving blood count, quality of life and reducing side effects.

Eligibility Criteria

This trial is for pregnant individuals less than 24 weeks along, with a hemoglobin level between 9.0 and 11.0 indicating iron deficiency anemia but not severe enough to require transfusion or IV therapy yet. They must have a single baby (singleton gestation) and no history of using IV iron in this pregnancy, sickle cell disease, severe organ disease, autoimmune conditions like SLE, or allergies to the study drugs.

Inclusion Criteria

Your blood test shows that you have mild anemia and low iron levels.

You have been diagnosed with iron deficiency anemia, which means your blood has low levels of hemoglobin or ferritin or total iron saturation.

Your ferritin level is below 30 or your total iron saturation is below 20.

Exclusion Criteria

You have previously received intravenous iron during this pregnancy.

You have severe anemia and need a blood transfusion or IV iron therapy.

Allergy or contraindication to either study drug

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous iron therapy (ferumoxytol) or oral iron therapy (ferrous sulfate) for treatment of iron deficiency anemia

90 days

2 visits (in-person) for IV group, daily oral intake for oral group

Follow-up

Participants are monitored for safety and effectiveness after treatment, including anemia resolution and quality of life assessments

9 months

Treatment Details

Interventions

• Ferrous Sulfate
• Ferumoxytol

Trial Overview The trial is testing whether starting intravenous (IV) iron therapy with Ferumoxytol during the second trimester is more effective than oral Ferrous Sulfate at improving blood count and quality of life while reducing side effects in pregnant people with iron deficiency anemia.

Participant Groups

Group I: Intravenous Iron Experimental Treatment 1 Intervention

510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.

Group II: Oral Iron Active Control 1 Intervention

325mg oral iron (ferrous sulfate) twice daily

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Auerbach Hematology and Oncology

Collaborator

Trials

1

Recruited

80+

Findings from Research

In a randomized controlled trial with 124 pregnant participants, intravenous ferumoxytol significantly increased maternal hemoglobin levels by an average of 1.86 g/dL compared to only 0.79 g/dL with oral ferrous sulfate (P<.0001).

Intravenous ferumoxytol also resulted in greater improvements in iron indices, with significant increases in ferritin and iron levels, indicating it is a more effective treatment for iron-deficiency anemia in pregnancy than oral iron supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. Awomolo, AM., McWhirter, A., Sadler, LC., et al.[2023]

Intravenous iron sucrose complex (ISC) significantly increased hemoglobin levels in pregnant women with iron deficiency anemia more effectively than oral ferrous sulfate, achieving higher levels in a shorter time (6.9 weeks vs. 14.9 weeks).

The ISC treatment was well-tolerated with no major side effects reported, while a notable percentage of women in the ferrous sulfate group experienced gastrointestinal issues and poor compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. al-Momen, AK., al-Meshari, A., al-Nuaim, L., et al.[2022]

A study involving 120 pregnant women found that ferrous sulfate, ferrous fumarate, ferrous ascorbate, and carbonyl iron were equally effective in treating iron-deficiency anemia, as all improved hemoglobin levels and other blood parameters similarly.

While all iron preparations were cost-effective, ferrous fumarate had a higher incidence of adverse effects (56.7%), suggesting that it may be less tolerable compared to the other options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing the efficacy, tolerability, and cost of oral iron preparations in iron-deficiency anemia in pregnancy. Gamad, N., Saha, PK., Sharma, P., et al.[2021]

In a study involving 201 pregnant women with iron deficiency, intravenous (IV) iron treatment resulted in 91% of participants remaining non-anaemic, compared to only 73% in those receiving oral iron, demonstrating a significant advantage for IV iron (p < 0.001).

IV iron not only improved haemoglobin levels more effectively than oral iron over an 18-week period but also led to greater reductions in fatigue and enhancements in quality of life, with similar safety profiles between the two treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. Hansen, R., Sommer, VM., Pinborg, A., et al.[2023]

In a study of 150 pregnant women with anemia, daily administration of ferrous sulfate (60 mg) was found to be the most effective treatment, achieving a cure rate of 47% compared to 34% for twice a week and 27% for once a week.

While daily treatment was the most effective, it also led to more side effects like diarrhea and epigastric pain, suggesting that twice a week dosing is a viable alternative for those who cannot tolerate daily iron supplementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effectiveness of three regimens using ferrous sulfate to treat anemia in pregnant women]. de Souza, AI., Batista Filho, M., Ferreira, LO., et al.[2019]

Ferumoxytol, an intravenous iron treatment approved by the FDA for iron deficiency anemia in patients with chronic kidney disease, significantly increased hemoglobin levels by about 1.0 g/dL over 35 days, outperforming oral iron treatments.

While ferumoxytol is effective, it carries safety concerns, including a 0.2% risk of serious hypersensitivity reactions and a 1.9% incidence of hypotension, highlighting the need for monitoring during administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. Lu, M., Cohen, MH., Rieves, D., et al.[2013]

Ferumoxytol is as effective and safe as other intravenous iron formulations, with moderate quality evidence showing little to no difference in treatment-emergent adverse events and serious adverse events across studies involving 5691 participants.

While ferumoxytol had fewer treatment-emergent adverse events compared to oral iron, it was associated with more adverse events compared to placebo, indicating a need for careful monitoring when used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety and efficacy of ferumoxytol in the treatment of iron deficiency: a systematic review and meta-analysis. Abdulrehman, J., Tang, GH., Auerbach, M., et al.[2021]

Ferumoxytol, an intravenous treatment for iron deficiency anemia, can cause significant imaging artifacts in brain MRIs performed within 3 days of administration, affecting the diagnostic quality of the scans.

Recognizing these artifacts, such as susceptibility effects on various MRI sequences and altered vascular signals, is crucial for clinicians to avoid misinterpretations and unnecessary follow-up examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental ferumoxytol artifacts in clinical brain MR imaging. Bowser, BA., Campeau, NG., Carr, CM., et al.[2018]

In a study of 187 pregnant women with iron deficiency anemia, those treated with ferrous bis-glycinate experienced a significantly greater increase in hemoglobin levels (2.48 g/dL) compared to those receiving ferrous glycine sulfate (1.32 g/dL) after 8 weeks.

Ferrous bis-glycinate not only proved to be more effective, with 89.2% of women reaching hemoglobin levels above 11 g/dL, but also had a better safety profile, as the rate of adverse effects was significantly higher in the ferrous glycine sulfate group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial. Abbas, AM., Abdelbadee, SA., Alanwar, A., et al.[2020]

In a study of 173 hemodialysis patients, both ferumoxytol and sodium ferric gluconate were effective in maintaining hemoglobin levels, showing no significant differences in hemoglobin or ESA utilization after 3 months.

However, patients receiving ferumoxytol had lower iron indices and required more blood transfusions compared to those treated with sodium ferric gluconate, indicating that while both treatments are effective, sodium ferric gluconate may provide better iron management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ferumoxytol versus sodium ferric gluconate in anemia management in outpatient hemodialysis patients: A prospective cohort study. El Nekidy, WS., El-Masri, MM., Kadri, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

A randomized controlled trial comparing the efficacy, tolerability, and cost of oral iron preparations in iron-deficiency anemia in pregnancy. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

[The effectiveness of three regimens using ferrous sulfate to treat anemia in pregnant women]. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

The safety and efficacy of ferumoxytol in the treatment of iron deficiency: a systematic review and meta-analysis. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Incidental ferumoxytol artifacts in clinical brain MR imaging. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial. [2020]

10. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of ferumoxytol versus sodium ferric gluconate in anemia management in outpatient hemodialysis patients: A prospective cohort study. [2021]