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Iron showdown: IV vs pills for anemia after gastric bypass

NCT ID NCT04268849

Disease control Sponsor: Auerbach Hematology Oncology Associates P C Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether intravenous iron works better than oral iron pills for treating iron deficiency anemia in people who have had gastric bypass or sleeve gastrectomy surgery. About 104 participants will be randomly assigned to receive either a single IV dose of ferumoxytol or daily oral ferrous sulfate. The main goal is to see which treatment improves hemoglobin levels and overall well-being more quickly, with results checked at 6 weeks and again at 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ferumoxytol (intravenous iron) and ferrous sulfate (oral iron)
What this could lead to
If IV iron proves more effective, it could become the preferred treatment for iron deficiency anemia after bariatric surgery, offering faster relief with fewer side effects.
What could go wrong
This is a relatively small trial (104 people) and results may not apply to all patients. Oral iron is the current standard, and IV iron carries rare risks like allergic reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 104 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2020

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: 1. Aged ≥ 18 years 2. Patients who have undergone a Roux-en Y Gastric Bypass or Vertical Sleeve Gastrectomy and are at least 3 months or more out from surgery. 3. Iron deficiency anemia defined as iron deficient with either ferritin\<30 mcg/l, TSAT\<20%, or anemia with Hgb\<13 g/dL for both males and females. 4. Willingness to participate and signing the informed consent form. Exclusion criteria: 1. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis) 2. Decompensated liver cirrhosis or active hepatitis (ALAT \> 3 times upper limit of normal) 3. Serum ferritin \> 400 ng/mL or transferrin saturation \>40 % 4. Active acute or chronic infections (assessed by clinical judgment that may be indicated by White Blood Cells (WBC) and C-Reactive Protein (CRP) when these are available) 5. Rheumatoid arthritis with symptoms or signs of active inflammation 6. Pregnant and nursing women 7. History of multiple allergies (two or more) 8. Known hypersensitivity to ferumoxytol or oral iron or any excipients in the drug products 9. Previous IV iron treatment for IDA 10. Other iron treatment or blood transfusion within 4 weeks prior to the screening or treatment visit 11. Planned elective surgery during the study 12. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. a malignancy, uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus

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Conditions

The condition(s) this trial relates to.

iron deficiency anemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Iron deficiency anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Auerbach Hematology and Oncology

    RECRUITING

    Baltimore, Maryland, 21237, United States

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