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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)

RecruitingPhase 3

A Phase 3, Randomized, Open-Label, Multicenter 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)

Who can join

Ages 2 to 17 · All sexes

Full eligibility criteria
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

About the study

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.

What is being tested

Sponsor: AMAG Pharmaceuticals, Inc. · Participants: 129 · Started: Aug 13, 2018

Contact the study team

Official record on ClinicalTrials.gov — NCT03619850

Locations in the U.S.

FloridaMemorial Healthcare System, Hollywood (Not yet recruiting)
MissouriChildren's Mercy Hospital, Kansas City
New YorkThe Feinstein Institute Medical Research Organization of Northwell Health, Inc., Lake Success (Not yet recruiting)
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM), The Bronx
OhioAkron Nephrology Associates, Inc., Akron
West VirginiaWest Virginia University, Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.