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New iron drug could help anemic kids with kidney problems

NCT ID NCT03619850

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 drug called ferumoxytol, a type of intravenous iron, to treat iron deficiency anemia in children aged 2 to 17 with chronic kidney disease. The trial compares ferumoxytol to another iron drug, iron sucrose, to see which is safer and works better. About 129 children will take part, and the main goal is to see if their hemoglobin levels improve within 5 weeks.

What this could mean

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

Active substance
Ferumoxytol (a form of intravenous iron)
What this could lead to
If it works, this could offer a safer and more effective way to treat iron deficiency anemia in children with chronic kidney disease.
What could go wrong
This is a phase 3 trial, but it's still relatively small (129 participants) and open-label, which can introduce bias. There are also risks like allergic reactions or low blood pressure.

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 129 people

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

Started

Aug 2018

Expected to finish

Aug 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: a) hemoglobin \<12.0 g/dL and b) with either transferrin saturation (TSAT) \<40% or ferritin \<100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT\<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin \<12 g/dL 3. Has Chronic Kidney Disease defined as one of the following: 1. on chronic hemodialysis; 2. receiving chronic peritoneal dialysis; 3. estimated glomerular filtration rate (eGFR) of \<60 mL/min/1.73 m2; 4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for \> 3 months. 4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate 5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study Exclusion Criteria: 1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose 2. History of allergy to intravenous (IV) iron 3. History of multiple drug allergies (\>2) 4. Low systolic blood pressure (Age 1-9 years \<70 + \[age in years x 2\] mmHg, Age 10-17 years \<90 mmHg) 5. Hemoglobin ≤7.0 g/dL 6. Serum ferritin level \>600 ng/mL

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome iron deficiency anemia

As listed by the trial registrant

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

Chronic kidney disease; 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

    16 sites in 5 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

  • Akron Nephrology Associates, Inc.

    RECRUITING

    Akron, Ohio, 44302, United States

  • Children's Mercy Hospital

    RECRUITING

    Kansas City, Missouri, 64108, United States

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

    RECRUITING

    Guadalajara, Mexico

  • Hospital of Lithuanian University of Health Sciences Kauno klinikos

    NOT_YET_RECRUITING

    Kaunas, Lithuania

  • Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)

    ACTIVE_NOT_RECRUITING

    New York, New York, 10029, United States

  • Instituto Mexicano De Trasplantes S.C

    RECRUITING

    Cuernavaca, Mexico

  • Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)

    RECRUITING

    Mexico City, Mexico

  • JM Research, SC

    ACTIVE_NOT_RECRUITING

    Cuernavaca, Mexico

  • Klaipeda Children's Hospital

    ACTIVE_NOT_RECRUITING

    Klaipėda, Lithuania

  • Memorial Healthcare System

    NOT_YET_RECRUITING

    Hollywood, Florida, 33021, United States

  • Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

    RECRUITING

    The Bronx, New York, 10467, United States

  • Polish Mother's Memorial Hospital Research Institute

    NOT_YET_RECRUITING

    Lodz, Poland

  • Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika

    RECRUITING

    Budapest, Hungary

  • Specjalistyczne Gabinety Sp. z o.o

    ACTIVE_NOT_RECRUITING

    Krakow, Poland

  • The Feinstein Institute Medical Research Organization of Northwell Health, Inc.

    NOT_YET_RECRUITING

    Lake Success, New York, 11042, United States

  • University Children Hospital

    NOT_YET_RECRUITING

    Krakow, Poland

  • University Of Szeged

    RECRUITING

    Szeged, Hungary

  • Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku

    NOT_YET_RECRUITING

    Bialystok, Poland

  • Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)

    NOT_YET_RECRUITING

    Vilnius, Lithuania

  • Wayne State University

    ACTIVE_NOT_RECRUITING

    Detroit, Michigan, 48201, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26506, United States

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Other studies related to the condition(s) this trial covers.