Monoferric for Iron Deficiency in Pregnancy

Overseen By Women's Health Research Unit Research Unit Department of OB/Gyn

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Oregon Health and Science University

Must be taking: IV iron

Disqualifiers: Infectious, Inflammatory, Malignant, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

A prospective observational study of pregnant women with iron deficiency anemia and oral iron intolerance or advanced gestational age.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your healthcare provider.

What data supports the effectiveness of the drug Monoferric (Ferric Derisomaltose) for treating iron deficiency in pregnancy?

Research shows that intravenous ferric derisomaltose (Monoferric) is effective in quickly improving iron levels and reducing symptoms like fatigue in pregnant women with iron deficiency, especially when oral iron is not well tolerated. ^{1 2 3 4 5}

How is the drug Monoferric different from other treatments for iron deficiency in pregnancy?

Monoferric (ferric derisomaltose) is unique because it is given as an intravenous (IV) infusion, which can quickly increase iron levels in the body, unlike oral iron supplements that may take longer to work and can cause stomach upset. This makes it a good option for pregnant women who cannot tolerate oral iron or need a rapid increase in iron levels. ^{1 2 3 4 6}

Eligibility Criteria

This trial is for pregnant women over 18 with iron deficiency anemia who can't take oral iron or are past 28 weeks of pregnancy. They should have low hemoglobin and ferritin levels indicating anemia, and be willing to participate.

Inclusion Criteria

I am willing to participate in the study.

I am pregnant, in my second or third trimester, and have low iron levels and hemoglobin.

I am 18 or older, pregnant between 14-42 weeks, and my doctor recommends IV iron.

Exclusion Criteria

I don't have infections or conditions that could affect iron treatment results.

You have had a bad reaction to IV iron before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of 1,000 mg IV Monoferric

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

Follow-up assessment at 6 weeks postpartum

Treatment Details

Interventions

• Ferric Derisomaltose

Trial Overview The study is observing the effects of Ferric derisomaltose, a type of IV iron treatment, on pregnant women with iron deficiency who either can't tolerate oral iron supplements or are in their late stages of pregnancy.

Participant Groups

Group I: Ferric derisomaltose Experimental Treatment 1 Intervention

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?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

Findings from Research

Ferric carboxy maltose (FCM) is an effective treatment for iron deficiency and iron deficiency anemia in pregnant women, significantly increasing serum ferritin and hemoglobin levels within 6 weeks after infusion.

The improvements in ferritin and hemoglobin levels, as well as red blood cell indices, were sustained for at least 12 weeks post-treatment, indicating the long-lasting efficacy of FCM in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of ferric carboxy maltose in treatment of iron deficiency/iron deficiency anaemia during pregnancy. Obaid, M., Abdelazim, IA., AbuFaza, M., 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]

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 80 pregnant women with iron-deficiency anemia, iron(III) polymaltose complex (Maltofer) showed similar effectiveness to ferrous sulfate in increasing hemoglobin levels after 90 days, with a mean increase of 2.16 g/dL compared to 1.93 g/dL for ferrous sulfate.

Iron(III) polymaltose complex had a significantly better safety profile, with fewer adverse events reported (29.3% vs. 56.4% for ferrous sulfate), making it a preferable option for treating iron-deficiency anemia in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral iron(III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study. Ortiz, R., Toblli, JE., Romero, JD., et al.[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 study of 120 pregnant women with iron deficiency, supplementation with ferrous bisglycinate plus folinic acid showed significantly better iron absorption and hematological improvements compared to ferrous fumarate, despite a lower iron dosage.

The ferrous bisglycinate group reported fewer side effects, such as nausea and abdominal pain, indicating it may be a more tolerable option for managing iron deficiency during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial. Bumrungpert, A., Pavadhgul, P., Piromsawasdi, T., et al.[2023]

References

1. Poland pubmed.ncbi.nlm.nih.gov

Efficacy of ferric carboxy maltose in treatment of iron deficiency/iron deficiency anaemia during pregnancy. [2023]

2. Malaysia pubmed.ncbi.nlm.nih.gov

Efficacy of high-dose intravenous iron in middle-aged to elderly iron-deficient patients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral iron(III) polymaltose complex versus ferrous sulfate in pregnant women with iron-deficiency anemia: a multicenter, randomized, controlled study. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Ferrous Bisglycinate and Folinic Acid in the Control of Iron Deficiency in Pregnant Women: A Randomized, Controlled Trial. [2023]