Intravenous Iron Therapy for Iron Deficiency in Pregnancy

Overseen By Sarah Smith, MD, BSc

Age: 18 - 65

Sex: Female

Trial Phase: Phase 3

Sponsor: Saskatchewan Health Authority - Regina Area

Must not be taking: IV iron, Blood transfusions

Disqualifiers: Thalassemia, Liver cirrhosis, Cancer, 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: 5

Duration: 4-6 weeks

280 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find the best way to treat iron deficiency anemia in pregnant women with severe iron deficiency, which can cause health problems for both mother and baby. By comparing two IV iron treatments, iron sucrose and iron isomaltoside (also known as Ferric Derisomaltose, Monoferric, or Monofer), the researchers hope to determine if iron stores can be replenished with fewer healthcare visits. This trial may suit pregnant women who are at least 13 weeks along and have been diagnosed with moderate to severe iron deficiency anemia. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently being treated with IV iron products or have had a blood transfusion within 4 weeks prior to joining, you cannot participate.

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

Previous studies have shown that iron isomaltoside is safe for pregnant women. Research indicates that it can increase iron levels with just one visit and has a safety profile similar to other iron treatments. Another study found it effective without any serious side effects for both mothers and their babies.

For iron sucrose, studies have shown it to be generally safe and well-tolerated in pregnant women. In one study, only 9% of patients reported any negative side effects, which were mostly mild. Importantly, there were no negative effects on pregnancy outcomes.

Existing research suggests that both treatments are effective and safe for addressing iron deficiency during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Iron Isomaltoside and Iron Sucrose are unique treatments for iron deficiency in pregnancy because they offer faster replenishment of iron levels compared to oral iron supplements, which are the standard of care. Iron Isomaltoside can deliver up to 1000-1500 mg in one or two infusions, allowing for a quick and efficient boost of iron stores. This is particularly beneficial for pregnant women who need rapid correction of iron levels to support both their health and the baby's development. Iron Sucrose provides a flexible dosing schedule, with up to 1000 mg per week, making it adaptable to individual patient needs. Researchers are excited about these options because they could significantly improve the management of iron deficiency in pregnancy, ensuring better outcomes for both mothers and their babies.

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

Research has shown that iron isomaltoside, one of the treatments in this trial, effectively treats iron deficiency anemia in pregnant women by quickly boosting hemoglobin levels, which are crucial for oxygen transport in the blood, and reducing anemia symptoms. One study found that it allows for higher doses with fewer visits compared to other treatments, offering convenience for busy schedules. In contrast, iron sucrose, another treatment option in this trial, has improved hemoglobin levels more effectively than oral iron. Studies have indicated that women receiving iron intravenously, such as with iron sucrose, experience fewer side effects compared to taking iron pills. Both treatments are safe and effective for treating anemia during pregnancy, making them good options for improving health outcomes for both mothers and babies. ^{1 2 3 4 6}

Who Is on the Research Team?

Ryan Lett, MD, FRCPC

Principal Investigator

Saskatchewan Health Authority - Regina Area

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with moderate to severe iron deficiency anemia, defined by specific blood test results. They must be at least 13 weeks into their pregnancy and willing to attend all treatment and follow-up appointments. Women with kidney or heart disease, certain infections, iron utilization disorders, recent IV iron or transfusions, multiple pregnancies, serious allergies or other significant health issues are excluded.

Inclusion Criteria

You have low levels of hemoglobin, serum ferritin, or iron saturation, which indicate iron deficiency anemia.

Willing to participate and attend all planned follow up visits

I am willing to go to all appointments for iron treatments.

Exclusion Criteria

I have a rheumatic disease.

Current participation in any other interventional trial

I currently have an active infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either a single dose of IV iron isomaltoside or multiple doses of IV iron sucrose

4-6 weeks

1-3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including post iron infusion, at delivery, and 6 weeks postpartum

6 weeks postpartum

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Iron Isomaltoside 1000
• Iron Sucrose

Trial Overview

The study compares two intravenous (IV) iron treatments: ferric derisomaltose (iron isomaltoside) versus the standard treatment of iron sucrose in pregnant women with iron deficiency anemia. The aim is to correct IDA effectively with fewer healthcare visits and improve maternal and neonatal health outcomes.

How Is the Trial Designed?

Group I: Iron Sucrose Active Control 1 Intervention

Route: Intravenous Dosage: 100 mg/mL (maximum 300 mg per dose) Frequency: up to 3 doses per week or 1000 mg per week maximum Duration: until iron needs reached by simplified table

Group II: Iron Isomaltoside/ferric derisomaltose Active Control 1 Intervention

route: intravenous Dosage: 1000-1500 mg (100mg/mL), max dose 20mg/kg Frequency: max dose 1000 mg, if further doses required, must receive dosage divided Duration: one infusion or two infusions (dose dependent)

Iron Isomaltoside 1000 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Monoferric for:

• Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Approved in European Union as Monofer for:

• Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Approved in Canada as Monoferric for:

• Iron deficiency anemia in adult patients who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD)

Who Is Running the Clinical Trial?

Saskatchewan Health Authority - Regina Area

Lead Sponsor

Trials

29

Recruited

5,400+

Saskatchewan Centre for Patient-Oriented Research

Collaborator

Trials

12

Recruited

2,000+

Published Research Related to This Trial

In a study of 40 women with postpartum anemia, intravenous iron-sucrose led to a significant increase in hemoglobin levels (2.4 g/dl) compared to oral ferrous fumarate (1.2 g/dl) by day 14.

Intravenous iron-sucrose was found to be more effective in raising hemoglobin levels more quickly than oral ferrous fumarate, and it was administered without any serious side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron in postpartum anemia. Jain, G., Palaria, U., Jha, SK.[2022]

A study involving 213 pregnant women showed that a single high-dose infusion of intravenous iron isomaltoside (IV-IIM) is safe, with only 4.7% experiencing mild hypersensitivity reactions that resolved quickly.

Maternal and fetal outcomes, including hemoglobin levels at delivery, were similar between women who received IV-IIM and those who did not, indicating that IV-IIM is effective for treating iron deficiency during pregnancy without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy. Wesström, J.[2020]

In a trial involving 1512 patients with iron deficiency anemia, a single dose of 1000 mg iron isomaltoside (IIM) was found to be as safe as iron sucrose (IS), with very low rates of serious hypersensitivity reactions (0.3% for IIM vs 0.4% for IS).

IIM not only met the non-inferiority criteria for hemoglobin change but also resulted in a significantly faster hematological response within the first two weeks compared to IS, which requires multiple doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, multi-center, randomized comparison of iron isomaltoside 1000 versus iron sucrose in patients with iron deficiency anemia; the FERWON-IDA trial. Auerbach, M., Henry, D., Derman, RJ., et al.[2021]

In a trial involving 511 patients with iron deficiency anemia (IDA), iron isomaltoside was found to be more effective than iron sucrose, leading to a quicker increase in hemoglobin levels, with a significant proportion of patients achieving an increase of ≥2 g/dL within 5 weeks.

Both iron treatments were well tolerated, with only 0.6% of patients experiencing serious adverse reactions, and iron isomaltoside allowed for higher cumulative dosing in fewer administrations compared to iron sucrose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. Derman, R., Roman, E., Modiano, MR., et al.[2021]

In a study of 112 pregnant women with iron deficiency anemia, intravenous iron sucrose significantly increased hemoglobin levels more than oral ferrous fumarate after 4 weeks (22 ± 11.5 g/L vs 12 ± 9 g/L, p < 0.0001).

The intravenous group also showed a greater improvement in serum ferritin levels, with 55% of participants experiencing a hemoglobin increase of more than 20 g/L, compared to only 11% in the oral group, indicating that intravenous iron sucrose is more effective for correcting anemia and replenishing iron stores during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron sucrose v/s oral ferrous fumarate for treatment of anemia in pregnancy. A randomized controlled trial. Bhavi, SB., Jaju, PB.[2018]

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]

High-dose intravenous ferric derisomaltose (Monofer®) infusions of 500 and 1000 mg effectively corrected iron deficiency and iron deficiency anemia in elderly patients, leading to rapid improvements in laboratory parameters and symptoms like fatigue.

Intravenous iron administration is a viable treatment option for patients who cannot tolerate oral iron or have poor absorption, potentially reducing morbidity and mortality associated with untreated iron deficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of high-dose intravenous iron in middle-aged to elderly iron-deficient patients. Khiatani, D., Tay, HS., Cushway, TR.[2022]

A study involving 2018 pregnant women with moderate-to-severe iron deficiency anemia found that intravenous iron sucrose did not significantly improve clinical outcomes compared to standard oral iron therapy, leading to the trial being stopped due to futility.

Both treatment groups had similar rates of serious maternal and fetal adverse events, indicating that intravenous iron sucrose is not more effective than oral iron and does not pose additional safety risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial. Neogi, SB., Devasenapathy, N., Singh, R., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7448468/

Intravenous iron isomaltoside versus oral ...

In this randomised comparative, open-label, single-centre, phase IV trial, 200 pregnant women between 14 and 21 weeks of gestation who have iron deficiency ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S1701216325001938

Ferric Derisomaltose Versus Iron Sucrose in Pregnancy ...

Compared to IS, FD significantly reduced infusion times and the number of clinic visits for patients, while delivering higher doses of IV iron with higher ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05251493?term=IRON%20SUCROSE&rank=9

NCT05251493 | Ferric Derisomaltose (Iron Isomaltoside) ...

IDA is associated with poor neonatal outcomes and maternal morbidity. This clinical trial will compare IV iron isomaltoside to IV iron sucrose for correction ...

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hkjgom.org

hkjgom.org/home/article/download/308/301

Efficacy and safety of intravenous iron isomaltoside in ...

Conclusion: Iron isomaltoside (Monofer) is effective and safe for postpartum anaemia. It enables rapid improvement in Hb level and anaemic symptoms, even for ...

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cda-amc.ca

cda-amc.ca/sites/default/files/pdf/htis/2021/RB1603%20Iron%20Isomaltoside%20Final.pdf

Iron Isomaltoside for Anemia Due to Pregnancy, ...

No evidence was found regarding the clinical effectiveness of iron isomaltoside for non-pregnant patients with menorrhagia or other gynecologic indications. • ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/32270330/

Safety of intravenous iron isomaltoside for iron deficiency ...

Purpose: To evaluate the efficacy and safety for mother and child of using intravenous iron isomaltoside (IV-IIM) during pregnancy. Methods: Using an ...