IV vs Oral Iron for Iron-Deficiency Anemia

Overseen By Michael Auerbach, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Auerbach Hematology Oncology Associates P C

Must not be taking: Blood transfusions

Disqualifiers: Iron overload, Liver cirrhosis, Infections, Pregnancy, Allergies, 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: Unknown

Duration: 6 weeks

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether oral or IV iron is more effective for treating iron deficiency anemia in individuals who have undergone weight-loss surgery. Suitable candidates include those who have had a Roux-en-Y gastric bypass or vertical sleeve gastrectomy and are experiencing symptoms of low iron, such as fatigue or shortness of breath, post-surgery. The study will compare the effectiveness and speed of each treatment in improving iron levels. Participants will be randomly assigned to either the oral iron group, taking ferrous sulfate tablets, or the IV iron group, receiving ferumoxytol (also known as Feraheme), with progress monitored over several weeks. If the initial treatment proves ineffective, participants may have the opportunity to try the alternative option. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to potentially groundbreaking treatment advancements.

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

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any other iron treatment or blood transfusion within 4 weeks before the trial.

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

Previous studies have shown that taking iron pills, such as ferrous sulfate, effectively treats iron deficiency anemia, though they often cause unpleasant side effects. Many people report stomach issues, including irritation, nausea, and constipation, which can make continuing treatment difficult.

In contrast, research has shown that intravenous iron, like ferumoxytol, is generally gentler on the body. Side effects are usually mild, including nausea and dizziness. One study with about 2,000 patients found that only a small percentage experienced these mild side effects.

Both treatments are already used to treat iron deficiency anemia and are considered safe for regular use. However, individual reactions can vary. Consulting a healthcare provider is essential to determine the best option. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for iron-deficiency anemia because they explore different ways to deliver iron to the body. Unlike traditional oral iron supplements like ferrous sulfate tablets, which can take weeks to show effectiveness, Ferumoxytol is given as an intravenous infusion that may work faster. This method might also bypass common side effects of oral iron, such as stomach upset. By comparing these two approaches, researchers hope to find out if one method is more effective or better tolerated, providing new insights into managing iron-deficiency anemia.

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

This trial will compare the effectiveness of oral iron, specifically ferrous sulfate tablets, with IV iron, specifically ferumoxytol, for treating iron-deficiency anemia (IDA). Research has shown that taking ferrous sulfate orally is a common treatment for IDA and can help increase hemoglobin levels. However, its effectiveness can be limited due to potential stomach upset and inconsistent absorption. Studies indicate it can raise hemoglobin by about 2 g/dL in a few weeks, but not everyone experiences complete relief from their anemia.

In contrast, ferumoxytol, an iron treatment administered through an IV, has proven very effective at increasing hemoglobin and iron levels, even in individuals who did not respond well to other treatments. Research suggests that ferumoxytol can lead to significant improvements in hemoglobin and overall iron levels, often outperforming oral treatments. These studies indicate that ferumoxytol may offer a quicker and more reliable boost in iron levels, with fewer stomach issues. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had Roux-en-Y Gastric Bypass or Vertical Sleeve Gastrectomy at least 3 months ago and are now facing iron deficiency anemia. It's not for those with iron utilization disorders, planned surgeries during the study, pregnant/nursing women, liver issues, multiple allergies, active infections, recent IV iron treatments or known hypersensitivity to the drugs tested.

Inclusion Criteria

Willingness to participate and signing the informed consent form

You have had a certain type of weight loss surgery at least 3 months ago.

You have low iron levels or anemia, as indicated by specific blood test results.

Exclusion Criteria

You have a condition that causes too much iron to build up in your body or makes it hard for your body to use iron.

Pregnant and nursing women

You have severe liver cirrhosis or active hepatitis with very high liver enzyme levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either oral ferrous sulfate or intravenous ferumoxytol for iron deficiency anemia

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Open-label extension (optional)

Non-responders at 6 weeks may receive open-label IV iron treatment and will be followed with the same evaluations

What Are the Treatments Tested in This Trial?

Interventions

• Ferrous sulfate tablets
• Ferumoxytol

Trial Overview The study compares oral ferrous sulfate tablets with intravenous (IV) Ferumoxytol in treating post-operative bariatric surgery patients with iron deficiency anemia. Participants will be randomly assigned to one of these two treatments and monitored for efficacy and speed of response over a period that includes a primary outcome measure at 6 weeks and follow-up at 12 months.

How Is the Trial Designed?

Group I: Oral Iron Active Control 4 Interventions

The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.

Group II: IV Iron Active Control 4 Interventions

The subject will receive one IV infusion of ferumoxytol administered as 1020 mg over 30 minutes or an equivalent volume of normal saline. At the time of the infusion, the patient will also be given an opaque bottle, containing either vitamin C tablets or ferrous sulfate 325 mg.

Who Is Running the Clinical Trial?

Auerbach Hematology Oncology Associates P C

Lead Sponsor

Trials

5

Recruited

440+

AMAG Pharmaceuticals, Inc.

Industry Sponsor

Trials

44

Recruited

11,300+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12188945/

Efficacy of Ferrous Sulphate in the Management of Iron ... [8]. A study reported that ferrous sulfate was (86.7%) effective among children in the management of iron deficiency anemia [9].

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10939879/

Oral Iron Therapy: Current Concepts and Future Prospects ... After 12 weeks of treatment, FeSO4 increased Hb levels more effectively (11.9 g/dL vs 11.1 g/dL), resolved IDA more frequently (29% vs 6%) and caused less ...

3. emedicine.medscape.com emedicine.medscape.com/article/202333-treatment

Iron Deficiency Anemia Treatment & Management Iron Therapy. Oral ferrous iron salts are the most economical and effective medication for the treatment of iron deficiency anemia. Of the ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2819337

Optimal Oral Iron Therapy for Iron Deficiency Anemia ... In this cohort study, all different oral iron strategies improved hemoglobin and iron indices but at slower paces in alternate day dosing.

5. haematologica.org haematologica.org/article/view/haematol.2024.284967

Oral iron supplementation: new formulations, old questions An optimal response to oral iron therapy is expected to increase hemoglobin by 2 g/dL within 3-4 weeks., A hemoglobin increase of 1 g/dL within ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39651609/

Effect and safety of intravenous iron compared to oral ... Intravenous iron likely does not increase AEs and may not increase serious AEs; however, the 95% CIs in both cases include potential harm.

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK557376/

Iron Supplementation - StatPearls - NCBI Bookshelf - NIH If left untreated, this may lead to adverse events such as neurodevelopmental delay in developing children and poor pregnancy outcomes for expectant mothers. At ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0098299720300364

Oral iron supplementation in iron-deficient women Oral iron supplementation can be an effective strategy to treat and prevent IDA, but guidelines vary. Some experts recommend doses of 150–200 mg elemental iron ...