A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Recruiting now · Phase 3

Conditions studied: Chronic Kidney Disease; Iron Deficiency Anemia

In brief

Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

Key facts

Study ID: NCT03619850
Run by: AMAG Pharmaceuticals, Inc.
People needed: 129
Starts: 2018-08-13
Expected to finish: 2026-08-31
Last updated by the study team: 2026-04-17

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female 2 years to <18 years of age at time of consent
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
Has Chronic Kidney Disease defined as one of the following:
on chronic hemodialysis;
receiving chronic peritoneal dialysis;
estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;
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.
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
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

You may not qualify if…

Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
History of allergy to intravenous (IV) iron
History of multiple drug allergies (>2)
Low systolic blood pressure (Age 1-9 years <70 + [age in years x 2] mmHg, Age 10-17 years <90 mmHg)
Hemoglobin ≤7.0 g/dL
Serum ferritin level >600 ng/mL

Where it is running

Akron Nephrology Associates, Inc. — Akron, Ohio, United States (enrolling)
Instituto Mexicano De Trasplantes S.C — Cuernavaca, Mexico (enrolling)
West Virginia University — Morgantown, West Virginia, United States (enrolling)
Hospital Civil de Guadalajara Fray Antonio Alcalde — Guadalajara, Mexico (enrolling)
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) — Mexico City, Mexico (enrolling)
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika — Budapest, Hungary (enrolling)
University Of Szeged — Szeged, Hungary (enrolling)
Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) — The Bronx, New York, United States (enrolling)
Specjalistyczne Gabinety Sp. z o.o — Krakow, Poland
University Children Hospital — Krakow, Poland
Memorial Healthcare System — Hollywood, Florida, United States
Polish Mother's Memorial Hospital Research Institute — Lodz, Poland
Wayne State University — Detroit, Michigan, United States
The Feinstein Institute Medical Research Organization of Northwell Health, Inc. — Lake Success, New York, United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) — New York, New York, United States
Hospital of Lithuanian University of Health Sciences Kauno klinikos — Kaunas, Lithuania
Klaipeda Children's Hospital — Klaipėda, Lithuania
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital) — Vilnius, Lithuania
JM Research, SC — Cuernavaca, Mexico
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku — Bialystok, Poland

Full record on ClinicalTrials.gov

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