Intravenous Iron for Iron-Deficiency Anemia

(POAM Trial)

Recruiting at 2 trial locations

Overseen By Keyvan Karkouti, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Complex surgery, Iron overload, Liver cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether IV iron therapy (Monoferric Injectable Product) can aid recovery after heart surgery in individuals with chronic iron-deficiency anemia, a condition characterized by insufficient healthy red blood cells due to low iron. Participants will receive either the iron treatment or a placebo (a harmless substance with no therapeutic effect) to determine if it enhances recovery and increases the number of days spent at home within 90 days post-surgery. This trial suits individuals undergoing non-emergency heart surgery with a heart-lung machine who have been diagnosed with iron-deficiency anemia. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Monoferric, the treatment being tested in this trial, is generally safe for people with iron deficiency anemia. In studies involving over 3,000 patients, Monoferric proved to be safe and effectively treated anemia without causing many serious side effects. Compared to similar treatments, Monoferric has a better safety record, causing fewer unwanted reactions in patients. Therefore, for those considering joining this trial, the treatment has already been well-tolerated by many individuals. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike traditional oral iron supplements for iron-deficiency anemia, Monoferric offers a unique intravenous option by delivering ferric derisomaltose directly into the bloodstream. This method bypasses the digestive system, which can reduce common side effects like nausea and gastrointestinal discomfort associated with oral iron pills. Additionally, Monoferric can deliver a higher dose in a single session, potentially restoring iron levels more quickly and efficiently, which is why researchers are eager to explore its benefits.

What evidence suggests that this treatment might be an effective treatment for iron-deficiency anemia?

Research shows that Monoferric, an injectable iron product, effectively treats iron-deficiency anemia (IDA). Studies have found that it quickly and steadily boosts iron levels in people with IDA. One study showed that patients experienced higher hemoglobin levels, indicating improvement in their anemia. Another real-world study confirmed Monoferric's effectiveness and safety in a large patient group. In this trial, participants in the intervention group will receive Monoferric to evaluate its impact on anemia recovery. These findings suggest that Monoferric might help patients recover from anemia faster after surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Justyna Bartoszko, MD

Principal Investigator

University Health Network, Toronto

Jeannie Callum, MD

Principal Investigator

Kingston Health Sciences Centre

Yulia Lin, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Are You a Good Fit for This Trial?

This trial is for patients with chronic iron-deficiency anemia who are undergoing cardiac surgery. They should be at one of the three participating Canadian centers. The study excludes those who don't meet the specific health criteria set by the researchers, but these aren't detailed here.

Inclusion Criteria

I am scheduled for a non-emergency heart surgery using a heart-lung machine.

I have low iron levels and anemia before surgery.

I am over 18 years old.

Exclusion Criteria

Patients who meet any of the following criteria are not eligible for the study:

Established contraindications to IV iron: hypersensitivity to the iron product, history of >2 food and/or drug allergic reactions (excluding drug intolerance), non-iron deficiency anemias such as myelodysplastic syndrome, history of iron overload or disturbances in use of iron such as hemochromatosis or hemosiderosis, decompensated liver cirrhosis (MELD ≥ 19) or active hepatitis, active infection, preoperative unstable hemodynamics defined as the requirement for vasopressors or inotropes, or active bleeding (as noted in the clinical record and/or defined as a requirement for red blood cell transfusion for ongoing clinical bleeding), refusal of blood products for religious or other reasons, known pregnancy, already enrolled in this trial, enrolment in another interventional trial which may impact anemia or transfusion management (for example, a trial of hemostatic therapies, such as tranexamic acid), receipt of intravenous iron at any point in the 6 weeks prior to randomization

I have undergone or need a complex heart-related surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV iron therapy or placebo shortly after cardiac surgery, with a possible repeat at 42 days post-surgery

6 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness, with primary outcomes measured at 90 days post-surgery

12 weeks

1 visit (in-person), additional follow-up as needed

What Are the Treatments Tested in This Trial?

Interventions

• Monoferric Injectable Product

Trial Overview The POAM trial is testing if giving IV iron therapy after cardiac surgery can help patients recover better compared to a saltwater placebo. It's done in two groups: one gets iron and the other gets placebo, chosen randomly.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 1 Intervention

Patients randomized to the IV iron group will receive 1000 mg ferric derisomaltose (Monoferric) diluted in 100 mL of 0.9 % sodium chloride solution, via intravenous infusion over 1 hour using an opaque IV bag and tubing for blinding.

Group II: Control group Placebo Group 1 Intervention

Patients randomized to the placebo group will receive 100 mL of 0.9 % sodium chloride solution via intravenous infusion using an opaque IV bag and tubing for blinding.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Heart and Stroke Foundation of Canada

Collaborator

Trials

131

Recruited

72,600+

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Kingston Health Sciences Centre

Collaborator

Trials

32

Recruited

34,400+

Published Research Related to This Trial

Iron isomaltoside 1000 (Monofer) is a novel intravenous iron formulation that has a very low immunogenic potential and allows for high single-dose administration, making it suitable for rapid iron repletion in patients with iron deficiency anemia.

Compared to other intravenous iron preparations, Monofer has significant advantages in terms of safety and convenience, enabling doses over 1000 mg to be given in a single infusion without the need for a test dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of the physicochemical properties of iron isomaltoside 1000 (Monofer), a new intravenous iron preparation and its clinical implications. Jahn, MR., Andreasen, HB., Fütterer, S., et al.[2022]

In a study involving 72 children, administering intravenous iron sucrose over 90 minutes resulted in only a few minor adverse events, indicating it is a safe method for treating anemia due to chronic renal impairment.

A faster infusion method of 2 mg/kg over 3 minutes was also safe, with only minor adverse events reported in 20 children, suggesting that both methods can be used effectively without life-threatening complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low incidence of adverse events following 90-minute and 3-minute infusions of intravenous iron sucrose in children on erythropoietin. Anbu, AT., Kemp, T., O'donnell, K., et al.[2019]

In a 12-month trial involving 39 European subjects with inflammatory bowel disease, iron isomaltoside 1000 effectively maintained hemoglobin levels above 12.0 g/dl in 74% of participants, demonstrating its efficacy in managing iron deficiency anemia.

The treatment was well-tolerated, with only minor hypersensitivity reactions reported, indicating a favorable safety profile for repeated high-dose intravenous iron administration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease. Reinisch, W., Altorjay, I., Zsigmond, F., et al.[2022]

Intravenous iron therapy significantly increases hemoglobin levels and reduces the need for blood transfusions, based on a meta-analysis of 72 trials involving 10,605 patients.

However, while effective, intravenous iron is associated with a higher risk of infection compared to oral or no iron supplementation, indicating a need for careful consideration in its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of intravenous iron therapy in reducing requirement for allogeneic blood transfusion: systematic review and meta-analysis of randomised clinical trials. Litton, E., Xiao, J., Ho, KM.[2022]

In a study involving 143 non-hemodialysis adult outpatients, both intravenous iron dextran and iron sucrose had similar rates of immediate severe drug reactions, indicating comparable safety in that regard.

However, iron sucrose was associated with a significantly higher risk of delayed infusion reactions compared to iron dextran, suggesting that while both treatments are generally safe, iron dextran may be preferable for minimizing delayed side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized double-blind safety comparison of intravenous iron dextran versus iron sucrose in an adult non-hemodialysis outpatient population: A feasibility study. Louzada, ML., Hsia, CC., Al-Ani, F., et al.[2020]

Oral iron supplementation is effective and cost-efficient for treating iron deficiency anemia (IDA), but it often causes gastrointestinal side effects and requires a long treatment duration.

New intravenous iron preparations, developed in the last five years, offer improved safety profiles and faster iron replenishment, allowing for higher doses without the risk of anaphylactic reactions associated with older formulations like iron dextran.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron therapy: how far have we come? Cançado, RD., Muñoz, M.[2021]

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]

Intravenous iron III-hydroxide saccharate was found to be an effective treatment for adult patients with iron deficiency anemia who did not respond well to oral iron therapy, with a significant increase in hemoglobin levels observed post-treatment.

Out of 25 patients studied, 68% achieved correction of anemia, and none required blood transfusions, highlighting the safety and efficacy of this treatment option, especially for those with severe anemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the efficacy of intravenous iron III-hydroxide saccharate for treating adult patients with iron deficiency anemia]. Cançado, RD., Brasil, SA., Noronha, TG., et al.[2019]

In a systematic review of five studies involving 694 patients with iron deficiency anemia, there was no significant difference in hemoglobin response between intravenous (IV) and oral (PO) iron treatments.

However, IV iron led to a greater initial increase in serum ferritin levels and a lower risk of withdrawal due to adverse events compared to PO iron, suggesting it may be a safer option for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iron Replacement in Patients with Inflammatory Bowel Disease: A Systematic Review and Meta-analysis. Abhyankar, A., Moss, AC.[2018]

Intravenous iron replacement is recommended for patients with severe iron deficiency, particularly when oral iron is ineffective or not tolerated, and in cases of inflammation that hinder iron absorption.

Current intravenous iron formulations have a strong safety profile, but potential side effects like skin staining, infusion reactions, and low phosphate levels should be monitored to ensure proper patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous iron: an update. Lucas, S., Garg, M.[2023]

Iron deficiency is the leading cause of anemia globally, and iron supplementation effectively increases transferrin saturation and ferritin levels, which helps raise hemoglobin and reduce anemia symptoms.

For patients who cannot absorb iron orally or have significant deficiencies, intravenous iron is necessary, and this paper reviews the available intravenous iron preparations, highlighting their benefits and risks associated with administering high doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SAFETY AND EFFICACY OF INTRAVENOUS ADMINISTRATION OF IRON PREPARATIONS. Grzywacz, A., Lubas, A., Fiedor, P., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10716724/

The Efficacy, Safety, and Economic Outcomes of Using ... FDI offers a safe, efficacious, and cost-effective treatment option for ID. It exhibits comparable efficacy to FCM and IS but presents a better safety profile ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40312072/

Initial effectiveness and safety data on intravenous ferric ... Our real-world data reveal FDI is rapidly and persistently effective in correcting IDA in paediatric gastroenterology.

3. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/11/04/14/19/ironman

Effectiveness of Intravenous Iron Treatment Versus ... The IRONMAN trial showed that iron (ferric derisomaltose) infusion is not superior to usual care among patients with HF and iron deficiency.

4. nature.com nature.com/articles/s41598-025-85880-9

Real-world evaluation of an intravenous iron service for the ... This retrospective audit assessed the effectiveness and safety of ferric derisomaltose (FDI), a high-dose IV iron, in 2,468 patients. Efficacy ...

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. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/208171s003lbl.pdf

Reference ID: 5423294 - accessdata.fda.gov The safety of Monoferric was evaluated in 3008 patients with iron deficiency anemia enrolled in two randomized, actively-controlled trials. Trial 1 enrolled ...

7. monoferric.com monoferric.com/

One dose IV Iron replacement | Monoferric® The safety and efficacy of Monoferric for treatment of iron deficiency anemia (IDA) were evaluated in two randomized, open-label, non-inferiority, actively ...