Actively Recruiting

Phase 3
Age: 2Years - 17Years
All Genders
NCT03619850

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

Age: 2Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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

Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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