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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, Ferric Derisomaltose (also known as Monoferric), for pregnant women with iron deficiency anemia who cannot tolerate oral iron or are further along in their pregnancy. The goal is to evaluate the effectiveness of this intravenous (IV) iron for these women. Suitable candidates are those who are 14 weeks or more into their pregnancy, have low iron levels, and struggle with oral iron supplements. As an Early Phase 1 trial, this research aims to understand how this new treatment works in people, offering participants the opportunity to be among the first to receive it.

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.

Is there any evidence suggesting that Ferric Derisomaltose is likely to be safe for humans?

Research has shown that ferric derisomaltose is safe for pregnant women. Studies have found that intravenous iron treatments, such as ferric derisomaltose, are both safe and effective during pregnancy. One study compared it to another iron treatment and found no negative effects on pregnancy outcomes, indicating the treatment is well-tolerated. Multiple studies support these findings, showing that iron infusions like ferric derisomaltose are a safe option for treating iron deficiency in pregnant women. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Ferric derisomaltose is unique because it offers a faster and potentially more convenient option for treating iron deficiency in pregnancy. Unlike traditional oral iron supplements that can take weeks to show results and often cause gastrointestinal side effects, ferric derisomaltose is administered intravenously, providing a rapid increase in iron levels with fewer stomach-related issues. Researchers are excited about this treatment because it could significantly improve the quality of life for pregnant individuals struggling with iron deficiency, ensuring they receive the necessary iron quickly and effectively.

What evidence suggests that Ferric Derisomaltose might be an effective treatment for iron deficiency in pregnancy?

Research shows that ferric derisomaltose, which participants in this trial will receive, effectively treats iron deficiency anemia in pregnant women. Studies indicate it increases hemoglobin (a protein in red blood cells that carries oxygen) and ferritin (a protein that stores iron) more effectively than iron pills. One study found that it helps pregnant women return to normal hemoglobin levels, resolving anemia. Ferric derisomaltose is particularly beneficial for those who cannot tolerate iron pills or require faster results due to late-stage pregnancy. It has shown promising results in boosting iron levels without the common side effects of iron pills. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10435604/

Intravenous ferric derisomaltose versus oral iron for ...

The trial results show that IV iron is superior to oral iron in preventing anaemia and improving Hb and ferritin levels in pregnant women with ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1701216325001938

Ferric Derisomaltose Versus Iron Sucrose in Pregnancy ...

This study uniquely highlights the benefits of TDI iron formulations using patient-important outcomes. Specifically, the use of TDIs in pregnancy reduced the ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05763043

NCT05763043 | Monoferric for Prenatal Iron Deficiency

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

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39909327/

Single-dose intravenous iron vs oral iron for treatment of ...

The dual primary outcomes were: (1) low birth weight (<2500 grams) and (2) attainment of a maternal nonanemic state (hemoglobin ≥11.0 g/dL at 30 ...

5.

ashpublications.org

ashpublications.org/blood/article/144/Supplement%201/5256/527288/Single-Dose-IV-Ferric-Derisomaltose-1000mg-given

Single-Dose IV Ferric Derisomaltose (1000mg given over 20 ...

Results: The primary outcome is the resolution of iron deficiency anemia, defined as a 1 g/dL increase in Hgb at 6 weeks postpartum following ...

6.

ashpublications.org

ashpublications.org/blood/article/142/Supplement%201/2381/502723/Efficacy-Safety-and-Tolerability-of-Iron-Infusions

Efficacy, Safety, and Tolerability of Iron Infusions in Pregnant ...

There were no adverse events that impacted a woman's pregnancy. Conclusions: Iron infusions in pregnant women are effective, safe, and well- ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9669178/

The Incidence, Complications and Treatment of Iron ...

Multiple clinical trials have found FCM to be safe in the second and third trimester of pregnancy. A prospective observational study analyzed data from 863 ...