Actively Recruiting
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)
Led by AMAG Pharmaceuticals, Inc. · Updated on 2026-04-17
129
Participants Needed
21
Research Sites
420 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 2 years to <18 years of age at time of consent
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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.
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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
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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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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