IV Iron Therapy for Uterine Bleeding

Overseen By Kelly R Keene, BSN

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Baylor College of Medicine

Must not be taking: Erythropoiesis-stimulating agents, Antithrombotics

Disqualifiers: Pregnancy, Hypersensitivity, Heart failure, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether IV Ferric Derisomaltose (an intravenous iron therapy) is more effective than oral iron pills for women with severe iron deficiency anemia due to heavy uterine bleeding. Participants will receive either a single IV dose of Ferric Derisomaltose or take ferrous sulfate pills daily for six weeks. Ideal candidates are women with ongoing uterine bleeding, moderate to severe anemia, and the ability to return home from the emergency department after treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment option.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain treatments like parenteral iron, erythropoiesis-stimulating agents, or antithrombotic therapy during the study period.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Ferric Derisomaltose is generally well-tolerated. In one study, 36 patients received the infusion, and only two experienced mild reactions. Importantly, no serious allergic reactions, such as anaphylaxis, occurred. This suggests that Ferric Derisomaltose is safe for most people, with minimal side effects.

Ferrous Sulfate, a common oral iron pill, has been used for many years and is usually considered safe. However, some individuals might experience stomach issues, such as nausea or constipation.

Both treatments aim to address iron deficiency, which means not having enough iron in the body. This can help alleviate symptoms like fatigue and weakness. These findings may help prospective trial participants feel more confident about the safety of the treatments being tested. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard oral iron supplements like ferrous sulfate, which require daily dosing and take weeks to show effectiveness, ferric derisomaltose offers a unique approach for treating uterine bleeding. This treatment is administered as a single intravenous dose, allowing for rapid iron replenishment, which could be especially beneficial for patients needing immediate relief. Researchers are excited about ferric derisomaltose because it not only simplifies the treatment regimen but also has the potential to improve adherence and outcomes by providing a quicker and more efficient solution to iron deficiency.

What evidence suggests that this trial's treatments could be effective for uterine bleeding?

Research has shown that Ferric Derisomaltose, an intravenous iron treatment, effectively treats severe iron deficiency anemia caused by heavy periods. Studies indicate it can safely raise hemoglobin levels by an average of 3.0 g/dL, boosting energy and improving overall quality of life. In this trial, participants will receive either Ferric Derisomaltose or oral Ferrous Sulfate. While oral Ferrous Sulfate is a common treatment for iron deficiency, it may work more slowly and be less effective for some individuals. Ferric Derisomaltose is often preferred for its faster action and fewer side effects. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for women with severe iron deficiency anemia due to uterine bleeding who can consent, are dischargeable from the emergency department, and can attend follow-ups. They must have a hemoglobin level of 9.0 g/dl or less and serum ferritin of 30 ng/mL or less. Exclusions include pregnancy, recent blood transfusions, major upcoming surgery, certain chronic diseases like heart failure or kidney disease, known allergies to iron treatments, and current infections.

Inclusion Criteria

Willing and able to provide consent for participation

I am cleared to leave the emergency department after treatment.

Your blood test shows low levels of ferritin, a sign of iron deficiency.

Exclusion Criteria

I need to be hospitalized for any reason.

I am scheduled for a major surgery during the study.

Pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either oral iron (ferrous sulfate 65 mg once daily for 42 days) or a single dose of intravenous ferric derisomaltose (1000 mg over at least 20 minutes)

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and changes in hemoglobin and ferritin levels

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ferric Derisomaltose
• Ferrous Sulfate

Trial Overview The study compares the effectiveness of IV Ferric Derisomaltose against oral Ferrous Sulfate in treating severe iron deficiency anemia caused by uterine bleeding in female patients at the emergency department. It's a randomized trial where participants will be assigned one of these two treatments.

How Is the Trial Designed?

Group I: Intravenous Ferric Derisomaltose Experimental Treatment 1 Intervention

One single dose of ferric derisomaltose, 1000 mg Intravenous over at least 20 minutes.

Group II: Oral Iron Active Control 1 Intervention

ferrous sulfate 65 mg once daily for 42 days.

Ferric Derisomaltose is already approved in United States, European Union for the following indications:

Approved in United States as Monoferric for:

• Iron deficiency anemia in adults with intolerance to oral iron or unsatisfactory response to oral iron or non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Approved in European Union as Monofer for:

• Iron deficiency anemia in adults with intolerance to oral iron or unsatisfactory response to oral iron or non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Pharmacosmos Therapeutics, Inc.

Collaborator

Trials

2

Recruited

70+

Published Research Related to This Trial

In a phase III study involving Japanese patients with iron deficiency anemia due to menorrhagia, intravenous ferric derisomaltose (FDI) was found to be noninferior to saccharated ferric oxide (SFO) in increasing hemoglobin levels, while allowing for a much higher single dose of up to 1000 mg compared to SFO's 120 mg.

FDI demonstrated a significantly lower incidence of treatment-emergent adverse events (66.2% vs. 90.8% for SFO) and a much lower rate of severe hypophosphatemia, indicating better safety and tolerability for patients receiving FDI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose versus saccharated ferric oxide for iron deficiency anemia associated with menorrhagia: a randomized, open-label, active-controlled, noninferiority study. Kawabata, H., Tamura, T., Tamai, S., et al.[2022]

Ferric carboxymaltose (FCM) is an effective treatment for iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding, showing significant improvements in ferritin and hemoglobin levels within 6 weeks after treatment in a study of 120 women aged 40 and older.

The safety profile of FCM was confirmed, with significant increases in red blood cell indices also observed, indicating that the benefits of treatment were sustained even 12 weeks post-infusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ferric carboxymaltose for treatment of iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding. Hagras, AM., Hussein, NA., Abdelazim, I., et al.[2023]

Ferric carboxymaltose (FCM) is as effective as iron sucrose (IS) for treating preoperative iron deficiency anemia (IDA) in women with menorrhagia, with 78.8% of FCM patients achieving hemoglobin levels ≥10 g/dL within 2 weeks compared to 72.3% for IS.

FCM leads to a significantly faster increase in hemoglobin levels, taking an average of 7.7 days to reach the target compared to 10.5 days for IS, while also reducing the need for multiple hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy and safety of intravenous ferric carboxymaltose and iron sucrose for the treatment of preoperative anemia in patients with menorrhagia: An open-label, multicenter, randomized study. Lee, S., Ryu, KJ., Lee, ES., et al.[2019]

In a large study of 7354 patients receiving ferric derisomaltose (FDI) for iron deficiency, the incidence of adverse reactions was very low, with only 1.7% experiencing any reactions and less than 0.1% having anaphylaxis, indicating that FDI is a safe treatment option.

Significant improvements in hemoglobin and ferritin levels were observed by Month 4 post-infusion, particularly in patients from surgical specialties, suggesting that FDI is effective in increasing iron levels in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience of intravenous ferric derisomaltose evaluated through safety and efficacy reporting in the UK. Sinclair, RCF., Nadaraja, S., Kennedy, NA., et al.[2023]

Intravenous ferric carboxymaltose (FCM) led to a significantly faster increase in hemoglobin levels compared to intravenous iron sucrose (ISC) at 6 weeks in patients with anemia due to abnormal uterine bleeding, indicating its efficacy in rapid treatment.

By 12 weeks, both FCM and ISC showed similar increases in hemoglobin levels, and the safety profiles of both treatments were comparable, suggesting that while FCM is quicker, both options are effective for long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial comparing ferric carboxymaltose and iron sucrose for treatment of iron deficiency anemia due to abnormal uterine bleeding. Mahey, R., Kriplani, A., Mogili, KD., et al.[2018]

Ferric derisomaltose is a newer intravenous iron formulation that allows for the delivery of 1000 mg of iron in a single infusion, significantly reducing the risk of serious hypersensitivity reactions (HSRs).

This formulation rapidly replenishes iron levels in patients, providing a convenient treatment option that minimizes adherence issues and lowers healthcare resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose for the treatment of iron deficiency anemia. Auerbach, M., Henry, D., DeLoughery, TG.[2021]

Intravenous iron therapy has become more common for treating iron deficiency, particularly in young women with heavy uterine bleeding and during pregnancy, expanding its use beyond dialysis-associated anemia.

New formulations of iron, such as low-molecular-weight iron dextran and ferric carboxymaltose, have been developed to reduce toxicity, making serious adverse events rare compared to older iron products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypersensitivity from intravenous iron products. Bircher, AJ., Auerbach, M.[2014]

Ferric derisomaltose is an effective intravenous iron treatment that allows for complete iron repletion in a single high-dose infusion, making it a rapid and cost-effective option for patients with iron deficiency.

It has a good safety profile, with rare occurrences of serious reactions like anaphylaxis and lower rates of hypophosphatemia compared to older intravenous iron formulations, indicating its suitability for a wide range of patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of ferric derisomaltose as a treatment for anemia. Kassianides, X., Bodington, R., Bhandari, S.[2021]

Modern intravenous (IV) iron products like ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and ferumoxytol (FER) have improved safety profiles, allowing for rapid administration of high doses to treat iron deficiency and iron deficiency anemia in large populations.

While immediate infusion reactions can occur, they are usually mild and severe reactions are rare; however, hypophosphatemia is a notable side effect of FCM, and ongoing trials will further assess the cardiovascular safety of these IV iron treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newer formulations of intravenous iron: a review of their chemistry and key safety aspects - hypersensitivity, hypophosphatemia, and cardiovascular safety. Blumenstein, I., Shanbhag, S., Langguth, P., et al.[2021]

In a study of 477 women with iron deficiency anemia due to heavy uterine bleeding, intravenous ferric carboxymaltose was significantly more effective than oral ferrous sulfate, with 82% of patients achieving a hemoglobin increase of 2.0 g/dL or more compared to 62% for oral iron.

Patients receiving ferric carboxymaltose also reported better improvements in vitality, physical function, and fatigue symptoms, with no serious adverse events noted, highlighting its safety and efficacy as a treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. Van Wyck, DB., Mangione, A., Morrison, J., et al.[2017]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11869313/

Iron deficiency anemia in patients with heavy menstrual ... Patients with IDA and HMB experienced substantial delays from symptom onset to subsequent IVI treatment, demonstrating a gap in management.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11803534/

Effect of Ferric Derisomaltose on Fatigue in Iron Deficiency ... ID can lead to fatigue and reduced quality of life, particularly in the context of abnormal menstrual bleeding [1]. Abnormal menstrual bleeding ...

3. hkjgom.org hkjgom.org/home/article/view/338

Safety and efficacy of ferric derisomaltose and its effect on ... Conclusion: Intravenous FDI is safe and effective for treating severe iron deficiency anaemia secondary to HMB. FDI significantly reduces the ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/pbc.31847?af=R

A Retrospective Single‐Center Study of Ferric ... There were 36 total infusions studied, with two infusion reactions and no cases of anaphylaxis. There was an average increase of 3.0 g/dL ...

5. nature.com nature.com/articles/s41598-025-85880-9

Real-world evaluation of an intravenous iron service for the ... This retrospective audit assessed the effectiveness and safety of ferric derisomaltose (FDI), a high-dose IV iron, in 2,468 patients.

6. hkjgom.org hkjgom.org/home/article/download/338/332/676

Safety and efficacy of ferric derisomaltose and its effect on ... Objective: This study investigates the safety and efficacy of ferric derisomaltose (FDI) and its effect on blood transfusion requirements in women with ...