Intravenous Iron Therapy for Iron Deficiency in Pregnancy

Recruiting in Palo Alto (17 mi)

Overseen by Ryan Lett, MD, FRCPC

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Saskatchewan Health Authority - Regina Area

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Ion deficiency anemia (IDA) is associated with poor neonatal outcomes and maternal morbidity. Iron replacement may be done with oral iron or intravenous iron, with intravenous iron being utilized later in pregnancy or if there is an inadequate response to oral iron in the first trimester. In Canada, iron sucrose has been used, however iron isomaltoside is as safe as other formulations of IV iron but can replete iron stores with a single visit. Replenishing iron stores reduces both maternal and neonatal risks and is supported by current guidelines. Iron status may play a role in depression, as well as anemia, bleeding and blood transfusion. The goal of this clinical trial: * Correct IDA with fewer visits and less impact on the healthcare system * Improve the health and well being of all pregnant women who are experiencing moderate to severe iron deficiency anemia.

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.

What data supports the idea that Intravenous Iron Therapy for Iron Deficiency in Pregnancy is an effective treatment?

The available research shows that Intravenous Iron Therapy, such as iron sucrose and ferric derisomaltose, is effective in treating iron deficiency in pregnant women. Studies comparing intravenous iron to oral iron treatments, like ferrous fumarate, indicate that intravenous iron can be more effective. For example, one study found that intravenous iron sucrose increased hemoglobin levels more effectively than oral iron in pregnant women with moderate-to-severe anemia. Another study showed that ferric derisomaltose was more effective than oral iron in women with persistent iron deficiency. These findings suggest that intravenous iron therapy can be a better option for improving iron levels during pregnancy. ^{1 2 3 4 5}

What safety data exists for intravenous iron therapy in pregnancy?

Intravenous iron therapies, including iron isomaltoside (also known as ferric derisomaltose) and iron sucrose, have been evaluated for safety in various studies. Iron isomaltoside has been shown to be well tolerated with a low incidence of serious adverse reactions (0.6%) and hypersensitivity reactions (0.3%). It also allows for higher cumulative dosing in fewer administrations compared to iron sucrose. Iron sucrose has been compared to oral iron therapies and shown to be effective, though its safety profile in pregnancy is still being established. Overall, both treatments have demonstrated a low frequency of hypersensitivity reactions and cardiovascular events, indicating a favorable safety profile for use in iron deficiency anemia, including during pregnancy. ^{1 2 5 6 7}

Is the drug Iron Isomaltoside 1000, Iron Sucrose a promising treatment for iron deficiency in pregnancy?

Yes, Iron Isomaltoside 1000 and Iron Sucrose are promising treatments for iron deficiency in pregnancy. They work quickly to improve iron levels and are well tolerated, making them effective options for pregnant women who need a rapid increase in iron. ^{1 3 5 7 8}

Research Team

Ryan Lett, MD, FRCPC

Principal Investigator

Saskatchewan Health Authority - Regina Area

Eligibility Criteria

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.

I am 18 years old or older.

Willing to participate and attend all planned follow up visits

Exclusion Criteria

I have a rheumatic disease.

Current participation in any other interventional trial

I currently have an active infection.

Treatment Details

Interventions

• Iron Isomaltoside 1000 (Iron Replacement Therapy)
• Iron Sucrose (Iron Replacement Therapy)

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.

Participant Groups

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)

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Regina General Hospital Regina, Canada

Who Is Running the Clinical Trial?

Saskatchewan Health Authority - Regina Area

Lead Sponsor

Trials

29

Patients Recruited

5,400+

Saskatchewan Centre for Patient-Oriented Research

Collaborator

Trials

12

Patients Recruited

2,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Safety of intravenous iron isomaltoside for iron deficiency and iron deficiency anemia in pregnancy. [2020] To evaluate the efficacy and safety for mother and child of using intravenous iron isomaltoside (IV-IIM) during pregnancy.

2. England pubmed.ncbi.nlm.nih.gov

Intravenous iron sucrose v/s oral ferrous fumarate for treatment of anemia in pregnancy. A randomized controlled trial. [2018] The objective of this study was to compare the efficacy, safety and tolerability of intravenous iron sucrose with that of oral ferrous fumarate in iron deficiency anemia during 14 to 34 weeks of pregnancy.

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

Intravenous ferric derisomaltose versus oral iron for persistent iron deficient pregnant women: a randomised controlled trial. [2023] To compare the efficacy of intravenous (IV) iron (ferric derisomaltose) with oral iron (ferrous fumarate) in women 14-21 weeks pregnant with persistent iron deficiency (ferritin

4. India pubmed.ncbi.nlm.nih.gov

Intravenous iron in postpartum anemia. [2022] To compare effectiveness of intravenous iron-sucrose versus oral ferrous fumarate in postpartum anemia.

5. England 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. [2020] Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy.

6. United States 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. [2021] Iron deficiency anemia (IDA) is prevalent, and intravenous iron, especially if given in a single dose, may result in better adherence compared with oral iron. The present trial (FERWON-IDA) is part of the FERWON program with iron isomaltoside 1000/ferric derisomaltose (IIM), evaluating safety and efficacy of high dose IIM in IDA patients of mixed etiologies. This was a randomized, open-label, comparative, multi-center trial conducted in the USA. The IDA patients were randomized 2:1 to a single dose of 1000 mg IIM, or iron sucrose (IS) administered as 200 mg intravenous injections, up to five times. The co-primary endpoints were adjudicated serious or severe hypersensitivity reactions, and change in hemoglobin from baseline to week eight. A total of 1512 patients were enrolled. The frequency of patients with serious or severe hypersensitivity reactions was 0.3% (95% confidence interval: 0.06;0.88) vs 0.4% (0.05;1.45) in the IIM and IS group, respectively. The co-primary safety objective was met, and no risk difference was observed between groups. The co-primary efficacy endpoint of non-inferiority in hemoglobin change was met, and IIM led to a significantly more rapid hematological response in the first two weeks. The frequency of cardiovascular events was 0.8% and 1.2% in the IIM and IS group, respectively (P = .570). The frequency of hypophosphatemia was low in both groups. Iron isomaltoside administered as 1000 mg resulted in a more rapid and more pronounced hematological response, compared with IS, which required multiple visits. The safety profile was similar with a low frequency of hypersensitivity reactions and cardiovascular events.

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

A randomized trial of iron isomaltoside versus iron sucrose in patients with iron deficiency anemia. [2021] Iron deficiency anemia (IDA) is common in many chronic diseases, and intravenous (IV) iron offers a rapid and efficient iron correction. This trial compared the efficacy and safety of iron isomaltoside (also known as ferric derisomaltose) and iron sucrose in patients with IDA who were intolerant of, or unresponsive to, oral iron. The trial was an open‐label, comparative, multi‐center trial. Five hundred and eleven patients with IDA from different causes were randomized 2:1 to iron isomaltoside or iron sucrose and followed for 5 weeks. The cumulative dose of iron isomaltoside was based on body weight and hemoglobin (Hb), administered as either a 1000 mg infusion over more than 15 minutes or 500 mg injection over 2 minutes. The cumulative dose of iron sucrose was calculated according to Ganzoni and administered as repeated 200 mg infusions over 30 minutes. The mean cumulative dose of iron isomaltoside was 1640.2 (standard deviation (SD): 357.6) mg and of iron sucrose 1127.9 (SD: 343.3) mg. The primary endpoint was the proportion of patients with a Hb increase ≥2 g/dL from baseline at any time between weeks 1‐5. Both non‐inferiority and superiority were confirmed for the primary endpoint, and a shorter time to Hb increase ≥2 g/dL was observed with iron isomaltoside. For all biochemical efficacy parameters, faster and/or greater improvements were found with iron isomaltoside. Both treatments were well tolerated; 0.6% experienced a serious adverse drug reaction. Iron isomaltoside was more effective than iron sucrose in achieving a rapid improvement in Hb. Furthermore, iron isomaltoside has an advantage over iron sucrose in allowing higher cumulative dosing in fewer administrations. Both treatments were well tolerated in a broad population with IDA.

8. Malaysia pubmed.ncbi.nlm.nih.gov

Efficacy of high-dose intravenous iron in middle-aged to elderly iron-deficient patients. [2022] Iron deficiency (ID) impacts about fifty percent of elderly patients with many symptoms present before iron deficiency anaemia . If left untreated, ID may increase morbidity and mortality. Oral iron is often not tolerated or the absorption is suboptimal. We describe our initial experiences of using high-dose intravenous ferric derisomaltose (Monofer®) infusions of 500 and 1000mg for iron deficiency and iron deficiency anaemia respectively in the outpatient setting. Rapid correction of laboratory parameters and improvement in common symptoms (such as fatigue) were observed. Intravenous iron may be an option for symptomatic iron deficient patients unsuitable for oral iron.