Actively Recruiting
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)
Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17
129
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and pharmacokinetics of ferumoxytol compared to iron sucrose in children with chronic kidney disease (CKD) who have iron deficiency anemia (IDA) or are at risk of developing it. The study focuses on pediatric patients aged 2 to under 18 years and aims to better understand ferumoxytol's profile in this group. This Phase 3, randomized, open-label study involves multiple centers and approximately 125 participants. Participants will be randomly assigned in a 2:1 ratio to receive either ferumoxytol or iron sucrose. Those in the ferumoxytol group will get two intravenous infusions of 7.0 mg Fe/kg (up to 510 mg per dose), the first on Day 1 and the second 2 to 8 days later. Those receiving iron sucrose will have dosing based on dialysis status: hemodialysis-dependent patients receive 2 mg Fe/kg on consecutive dialysis sessions for 10 doses, and non-hemodialysis-dependent or peritoneal dialysis-dependent patients receive 4 mg Fe/kg up to three times per week for 5 doses, with total maximum doses capped at 1000 mg. The study lasts up to 7 weeks, including a 2-week screening period and a 5-week treatment period. Researchers will monitor hemoglobin changes, adverse events, and special safety concerns during 49 days of follow-up. Assessments include blood tests to measure hemoglobin and iron levels, safety evaluations, and pharmacokinetic and pharmacodynamic analyses. This helps determine how participants respond and tolerate the treatments over time.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 2 to under 18 years at time of consent
- Has iron deficiency anemia defined by hemoglobin less than 12.0 g/dL and either transferrin saturation less than 40% or ferritin less than 100 ng/mL, or is at risk of developing iron deficiency anemia
- Has chronic kidney disease defined as being on chronic hemodialysis, receiving chronic peritoneal dialysis, having an estimated glomerular filtration rate below 60 mL/min/1.73 m2, or having structural or functional kidney abnormalities lasting more than 3 months
- For non-hemodialysis patients, has a documented history of unsatisfactory or intolerable oral iron therapy or oral iron is medically inappropriate
- If sexually active and of childbearing potential, agrees to use effective birth control from at least 1 month before dosing until study completion
You will not qualify if you...
- Known allergic reactions to ferumoxytol or iron sucrose
- History of allergy to intravenous iron
- History of multiple drug allergies (more than 2)
- Low systolic blood pressure below age-based thresholds
- Hemoglobin less than or equal to 7.0 g/dL
- Serum ferritin level greater than 600 ng/mL
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive either two IV infusions of ferumoxytol or multiple doses of iron sucrose depending on their dialysis status.
Multiple visits over 5 weeks for infusions and assessments
Trial Site Locations
Total: 21 locations
1
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Not Yet Recruiting
2
Wayne State University
Detroit, Michigan, United States, 48201
Active, Not Recruiting
3
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Actively Recruiting
4
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York, United States, 11042
Not Yet Recruiting
5
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, United States, 10029
Active, Not Recruiting
6
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
The Bronx, New York, United States, 10467
Actively Recruiting
7
Akron Nephrology Associates, Inc.
Akron, Ohio, United States, 44302
Actively Recruiting
8
West Virginia University
Morgantown, West Virginia, United States, 26506
Actively Recruiting
9
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest, Hungary
Actively Recruiting
10
University Of Szeged
Szeged, Hungary
Actively Recruiting
11
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Not Yet Recruiting
12
Klaipeda Children's Hospital
Klaipėda, Lithuania
Active, Not Recruiting
13
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
Vilnius, Lithuania
Not Yet Recruiting
14
Instituto Mexicano De Trasplantes S.C
Cuernavaca, Mexico
Actively Recruiting
15
JM Research, SC
Cuernavaca, Mexico
Active, Not Recruiting
16
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Mexico
Actively Recruiting
17
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City, Mexico
Actively Recruiting
18
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
Bialystok, Poland
Not Yet Recruiting
19
Specjalistyczne Gabinety Sp. z o.o
Krakow, Poland
Active, Not Recruiting
20
University Children Hospital
Krakow, Poland
Not Yet Recruiting
21
Polish Mother's Memorial Hospital Research Institute
Lodz, Poland
Not Yet Recruiting
Research Team
C
Clinical Trial Interest
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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