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New iron shot could help kids with anemia who Can't take pills

NCT ID NCT03893045

Disease control Sponsor: AMAG Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a medicine called ferumoxytol, given as an IV infusion, to treat iron deficiency anemia in children aged 2 to 17. It is for kids who cannot take or do not respond to oral iron supplements. The main goal is to see if it safely raises hemoglobin levels after 5 weeks.

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 75 people

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

Started

Sep 2019

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

2 to 17 years

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. Male or female 2 years to \<18 years of age at time of consent 2. Has IDA defined as: 1. Hemoglobin (Hgb) \<11.0 g/dL AND 2. Any one or more of the following: * Transferrin saturation (TSAT) \<20% * ferritin \<100 ng/mL 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of ≥2 clinically significant drug allergies 4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening) 5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg) 6. Hgb ≤7.0 g/dL 7. Serum ferritin level \>600 ng/mL

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Conditions

The condition(s) this trial relates to.

anemia 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

    15 sites in 3 countries. 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

  • Arkansas Children's Hospital

    NOT_YET_RECRUITING

    Little Rock, Arkansas, 72202, United States

  • Biomedical Research LLC

    RECRUITING

    Miami, Florida, 33184, United States

  • Centrum Zdrowia MDM

    NOT_YET_RECRUITING

    Warsaw, Poland

  • Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos

    NOT_YET_RECRUITING

    Vilnius, Lithuania

  • Gwinnett Research Institute

    NOT_YET_RECRUITING

    Buford, Georgia, 30519, United States

  • JSC Saules seimos medicinos centras

    NOT_YET_RECRUITING

    Kaunas, Lithuania

  • Klaipeda Children's Hospital

    NOT_YET_RECRUITING

    Klaipėda, Lithuania

  • Korczowski Bartosz, Gabinet Lekarski

    NOT_YET_RECRUITING

    Rzeszów, Poland

  • Optimus U Corporation

    RECRUITING

    Miami, Florida, 33125, United States

  • Osrodek Badan Klinicznych In Vivo sp. z o.o.

    NOT_YET_RECRUITING

    Bydgoszcz, Poland

  • Pro Familia Altera Sp. z o.o.

    NOT_YET_RECRUITING

    Katowice, Poland

  • Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek

    NOT_YET_RECRUITING

    Dębica, Poland

  • Sun Research Institute

    RECRUITING

    San Antonio, Texas, 78215, United States

  • University of Florida

    NOT_YET_RECRUITING

    Gainesville, Florida, 32608, United States

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    NOT_YET_RECRUITING

    Wroclaw, Poland

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