IV vs Oral Iron Therapy for Anemia in Pregnancy (EASI-A Trial)
Palo Alto (17 mi)Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Thomas Jefferson University
No Placebo Group
Prior Safety Data
Trial Summary
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.
What safety data exists for IV vs oral iron therapy in pregnancy?Safety data for ferumoxytol (Feraheme) includes hypersensitivity reactions and hypotension as primary concerns. Anaphylaxis or anaphylactoid reactions occurred in 0.2% of subjects, with other hypersensitivity-related adverse reactions in 3.7%. Hypotension was observed in 1.9% of patients, including serious cases. Ferumoxytol can also affect MRI diagnostics for up to 3 months. Comparatively, oral iron treatments like ferrous sulfate have been associated with higher rates of adverse effects in some studies.345610
What data supports the idea that IV vs Oral Iron Therapy for Anemia in Pregnancy is an effective treatment?The available research shows that intravenous (IV) iron treatments, like ferumoxytol and ferric derisomaltose, are more effective than oral iron treatments, such as ferrous sulfate and ferrous fumarate, for treating anemia in pregnancy. Studies comparing these treatments found that IV iron leads to better improvement in anemia. For example, one study found that IV ferumoxytol was superior to oral ferrous sulfate. Another study showed that IV ferric derisomaltose was more effective than oral ferrous fumarate in pregnant women with persistent iron deficiency. These findings suggest that IV iron treatments can be a more effective option for managing anemia during pregnancy.128910
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, if you have a history of medication allergy or reaction to IV iron products, you may not be eligible to participate.
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.Treatment Details
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Intravenous IronExperimental Treatment1 Intervention
510mg ferumoxytol intravenous infusion for two doses total; second dose 3-8 days after first dose.
Group II: Oral IronActive Control1 Intervention
325mg oral iron (ferrous sulfate) twice daily
Find a clinic near you
Research locations nearbySelect from list below to view details:
Thomas Jefferson University HospitalPhiladelphia, PA
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
Auerbach Hematology and OncologyCollaborator
References
Intravenous iron sucrose complex in the treatment of iron deficiency anemia during pregnancy. [2022]To evaluate the safety and efficacy of intravenous iron sucrose complex (ISC) as compared with oral ferrous sulfate in the treatment of iron deficiency anemia during pregnancy.
[The effectiveness of three regimens using ferrous sulfate to treat anemia in pregnant women]. [2019]To evaluate the effectiveness of three regimens employing ferrous sulfate to treat pregnant women with anemia.
FDA report: Ferumoxytol for intravenous iron therapy in adult patients with chronic kidney disease. [2013]On June 30, 2009, the United States Food and Drug Administration (FDA) approved ferumoxytol (Feraheme injection, AMAG Pharmaceuticals), an iron-containing product for intravenous (IV) administration, for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). The safety and efficacy of ferumoxytol were assessed in three randomized, open-label, controlled clinical trials. Two trials evaluated patients with nondialysis dependent CKD and a third trial assessed patients undergoing hemodialysis. Randomization was either to ferumoxytol or oral iron. Ferumoxytol was administered as two 510 mg IV injections, separated by 3-8 days. Oral iron, Ferro-Sequels, was administered at a dose of 100 mg twice daily for 21 days. In all three clinical trials, ferumoxytol administration increased the mean blood hemoglobin (Hgb) concentrations by approximately 1.0 g/dL over the 35 day period, a mean increase that was greater than what was observed in patients receiving oral iron. Patients receiving ferumoxytol also had increases in blood transferrin saturation (TSAT) and ferritin values. For the proposed ferumoxytol dosing regimen, 4.9% of patients had serum ferritin >or=800 ng/mL and TSAT >or=50% post-treatment. The most important ferumoxytol safety concerns were hypersensitivity reactions and/or hypotension. Anaphylaxis or anaphylactoid reactions were reported in 0.2% of subjects, and other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria, or wheezing) were reported in 3.7%. Hypotension was observed in 1.9%, including three patients with serious hypotensive reactions. Ferumoxytol administration may transiently affect the diagnostic ability of magnetic resonance imaging and the drug label provides further information regarding this effect.
Incidental ferumoxytol artifacts in clinical brain MR imaging. [2018]Ferumoxytol (Feraheme) is a parenteral therapy approved for treatment of iron deficiency anemia. The product insert for ferumoxytol states that it may affect the diagnostic ability of MRI for up to 3 months. However, the expected effects may not be commonly recognized among clinical neuroradiologists. Our purpose is to describe the artifacts we have seen at our institution during routine clinical practice.
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]Objective: The aim of this study is to compare the efficacy and tolerability of oral ferrous bis-glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia (IDA) with pregnancy.Methods: A randomized double-blind clinical trial (NCT02590224) conducted at a tertiary University Hospital in the period between 1 January 2016 and 31 July 2017 included pregnant women at 14-18 weeks of gestation with mild to moderate IDA. Patients were randomized into two groups: (Group I) received oral ferrous bis-glycinate tablets once daily for eight consecutive weeks and (Group II) received oral ferrous glycine sulfate capsules in the same dose and duration. The primary outcome of the study was the rate of increase of hemoglobin (HB) level after 8 weeks of iron treatment.Results: The study included 187 women in the final analysis. The mean increase in HB level after 8 weeks of treatment in ferrous bis-glycinate group was 2.48 ± 0.12 g/dL versus 1.32 ± 0.18 g/dL in ferrous glycine sulfate group (p ≤ .0001). The percentage of women with HB level more than 11 g/dL after 8 weeks of treatment was 89.2% in ferrous bis-glycinate group versus 71.3% in ferrous glycine sulfate group (p < .0001). The rate of adverse effects was significantly higher in ferrous glycine sulfate group (p = .001).Conclusions: Pregnant women with second trimester IDA could be supplied with ferrous bis-glycinate which is more efficient in increasing HB level. Moreover, it has tolerable adverse effects and high compliance than ferrous glycine sulfate.
The safety and efficacy of ferumoxytol in the treatment of iron deficiency: a systematic review and meta-analysis. [2021]Ferumoxytol is an intravenous (IV) iron formulation for treatment of iron deficiency (ID) that faced post-marketing reports of serious adverse events (SAEs).
Efficacy of ferumoxytol versus sodium ferric gluconate in anemia management in outpatient hemodialysis patients: A prospective cohort study. [2021]Intravenous iron is one of the main therapies for anemia management in hemodialysis-dependent patients. Data comparing the efficacy of ferumoxytol versus other parenteral iron supplements are scarce. The objective of the study was to compare the efficacy of ferumoxytol with that of sodium ferric gluconate in outpatient hemodialysis patients.
A randomized controlled trial comparing the efficacy, tolerability, and cost of oral iron preparations in iron-deficiency anemia in pregnancy. [2021]To evaluate the efficacy, tolerability, and cost of four commonly prescribed oral iron preparations: ferrous sulfate (FS), ferrous fumarate (FF), ferrous ascorbate (FA), and carbonyl iron (CI) in the treatment of iron-deficiency anemia (IDA) in pregnant women.
Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. [2023]To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14-21 weeks pregnant with persistent iron deficiency (ferritin
Intravenous infusions of ferumoxytol compared to oral ferrous sulfate for the treatment of anemia in pregnancy: a randomized controlled trial. [2023]Iron-deficiency anemia in pregnancy is highly prevalent and presents significant risk to patients. Initial treatment is often with oral medication. We hypothesized that intravenous ferumoxytol would result in superior treatment of anemia as compared to oral ferrous sulfate.