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

Trial Summary

What is the purpose of this trial?

The primary aim of this randomized trial is to assess the efficacy of IV Ferric Derisomaltose vs Oral Iron in the management of women with severe Iron Deficiency Anemia due to Uterine Bleeding in the emergency department.

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.

What data supports the effectiveness of the drug Ferric Derisomaltose for uterine bleeding?

A study showed that Ferric Derisomaltose is effective in increasing hemoglobin levels (a protein in red blood cells that carries oxygen) in patients with iron deficiency anemia due to heavy menstrual bleeding, and it had fewer side effects compared to another iron treatment. ^{1 2 3 4 5}

Is IV iron therapy with ferric derisomaltose safe for humans?

Ferric derisomaltose is generally safe for humans, with a low risk of serious allergic reactions and rare cases of low phosphate levels in the blood. Most side effects are mild, and severe reactions like anaphylaxis are extremely rare. ^{1 6 7 8 9}

How is the drug Ferric Derisomaltose different from other treatments for uterine bleeding?

Ferric Derisomaltose is unique because it can deliver a large dose of iron in a single intravenous infusion, which is convenient and reduces the need for multiple treatments. It also has a low risk of serious allergic reactions, making it safer for patients who cannot tolerate oral iron. ^{2 3 4 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

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]

References

1. Japan 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. [2022]

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

Large-dose intravenous ferric carboxymaltose injection for iron deficiency anemia in heavy uterine bleeding: a randomized, controlled trial. [2017]

3. Poland pubmed.ncbi.nlm.nih.gov

Ferric carboxymaltose for treatment of iron deficiency and iron deficiency anemia caused by abnormal uterine bleeding. [2023]

4. United States 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. [2018]

5. Australia 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. [2019]

6. England pubmed.ncbi.nlm.nih.gov

An evaluation of ferric derisomaltose as a treatment for anemia. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Newer formulations of intravenous iron: a review of their chemistry and key safety aspects - hypersensitivity, hypophosphatemia, and cardiovascular safety. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Real-world experience of intravenous ferric derisomaltose evaluated through safety and efficacy reporting in the UK. [2023]

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

Intravenous ferric derisomaltose for the treatment of iron deficiency anemia. [2021]

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

Hypersensitivity from intravenous iron products. [2014]