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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether intravenous (IV) iron therapy is more effective than oral iron pills for treating anemia during pregnancy. The researchers aim to determine if starting IV iron in the second trimester can improve blood counts, enhance quality of life, and reduce side effects compared to oral iron. Women pregnant with one baby, less than 24 weeks along, and previously diagnosed with iron deficiency anemia might be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and seeks to understand its benefits for more patients.

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 is the safety track record for these treatments?

Research has shown that ferumoxytol, administered as an IV treatment for anemia in pregnant women, is generally safe. In one study involving 131 pregnant women, ferumoxytol was well-tolerated, with no major safety issues reported. Another large study also supported its safety and effectiveness for treating anemia during pregnancy. However, animal studies have indicated some risks, such as birth defects, though these effects have not been observed in humans.

Ferrous sulfate, an oral iron supplement, is widely used and generally well-tolerated. Common side effects include stomach upset or constipation, but these are usually manageable.

Both treatments have been used safely in many pregnant women, with ferumoxytol demonstrating a good safety record in the studies mentioned. It is important to discuss potential risks and benefits with a healthcare provider before deciding on a treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the treatments for anemia in pregnancy because they offer different benefits compared to traditional oral iron supplements. Ferumoxytol, given intravenously, is unique because it allows for a much quicker delivery of iron directly into the bloodstream, potentially improving iron levels faster than oral options like ferrous sulfate. This could be particularly beneficial for pregnant women who need to boost their iron levels rapidly due to severe anemia. Additionally, intravenous administration can bypass common gastrointestinal side effects associated with oral iron, making it a promising alternative for those who struggle with tolerance to standard oral supplements.

What evidence suggests that this trial's treatments could be effective for anemia in pregnancy?

This trial will compare the effectiveness of intravenous iron therapy using ferumoxytol with oral iron therapy using ferrous sulfate for treating anemia in pregnancy. Studies have shown that intravenous iron, specifically ferumoxytol, is effective and safe for treating anemia in pregnant women. One study found that after receiving IV iron, 87% of participants had improved iron levels. In contrast, oral iron like ferrous sulfate is common but often causes more stomach issues and may not work as quickly. Research indicates that ferumoxytol can improve blood counts faster, and many women tolerate it better. Overall, IV iron may enhance quality of life during pregnancy by more effectively reducing anemia. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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 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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8170347/

Ferumoxytol for the treatment of iron deficiency and ... No serious adverse events were observed. The mean increments at 4 weeks and 8 weeks were 2.1 g/dl and 2.6 g/dl, respectively. In a retrospective ...

2. healio.com healio.com/news/hematology-oncology/20210702/ferumoxytol-effective-safe-for-iron-deficiency-iron-deficiency-anemia-of-pregnancy

Ferumoxytol effective, safe for iron deficiency ... Iron replacement with IV ferumoxytol appears effective and safe for iron-deficient pregnant women with anemia in their second or third trimester.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2589933323002057

Neonatal outcomes from a randomized controlled trial of ... This study aimed to investigate whether maternal treatment with intravenous ferumoxytol compared to oral ferrous sulfate results in an increase in neonatal ...

4. smfm.org smfm.org/news/large-study-finds-iv-iron-treatment-during-pregnancy-safe-and-effective-for-anemia

Large Study Finds IV Iron Treatment During Pregnancy ... One of the largest studies of its kind finds early intervention with iron delivered intravenously during pregnancy is a safe and effective treatment for anemia.

5. ashpublications.org ashpublications.org/blood/article/142/Supplement%201/2381/502723/Efficacy-Safety-and-Tolerability-of-Iron-Infusions

Efficacy, Safety, and Tolerability of Iron Infusions in Pregnant ... Two weeks after the final infusion, 87% were found to have iron saturation greater than 15%, 83% were found to have ferritin above 30, and 88% ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34104372/

Ferumoxytol for the treatment of iron deficiency and ... This study supports a growing body of evidence, to date, unreported, with ferumoxytol in pregnancy, reporting improved convenience and decreased ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/022180s025lbl.pdf

Feraheme. - accessdata.fda.gov In animal studies, administration of ferumoxytol to pregnant rabbits during organogenesis caused adverse developmental outcomes including fetal malformations ...