Ireland
--:--IST
Recruiting Phase 3

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)

NCT03619850 · tracked via the Priya Life Science Mexico tracker
Sponsor
AMAG Pharmaceuticals, Inc
Phase
Phase 3
Started
2018-08-13
Last updated
2026-04-17

Condition(s) studied

Chronic Kidney Disease; Iron Deficiency Anemia

Investigational drug(s) / intervention(s)

Ferumoxytol →Iron sucrose →

Ferumoxytol: Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.

Iron sucrose: Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).

Study summary

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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
17 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5 — 35 days
    Proportion of patients achieving a hemoglobin change of at least 0.5 g/dL during the period from Baseline to Week 5

Trial sites (21)

FacilityCityRegionStatus
Memorial Healthcare System Hollywood Florida Not Yet Recruiting
Wayne State University Detroit Michigan Active Not Recruiting
Children's Mercy Hospital Kansas City Missouri Recruiting
The Feinstein Institute Medical Research Organization of Northwell Health, Inc. Lake Success New York Not Yet Recruiting
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) New York New York Active Not Recruiting
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM) The Bronx New York Recruiting
Akron Nephrology Associates, Inc. Akron Ohio Recruiting
West Virginia University Morgantown West Virginia Recruiting
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika Budapest Hungary Recruiting
University Of Szeged Szeged Hungary Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos Kaunas Lithuania Not Yet Recruiting
Klaipeda Children's Hospital Klaipėda Lithuania Active Not Recruiting
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital) Vilnius Lithuania Not Yet Recruiting
Instituto Mexicano De Trasplantes S.C Cuernavaca Mexico Recruiting
JM Research, SC Cuernavaca Mexico Active Not Recruiting
Hospital Civil de Guadalajara Fray Antonio Alcalde Guadalajara Mexico Recruiting
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics) Mexico City Mexico Recruiting
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku Bialystok Poland Not Yet Recruiting
Specjalistyczne Gabinety Sp. z o.o Krakow Poland Active Not Recruiting
University Children Hospital Krakow Poland Not Yet Recruiting
Polish Mother's Memorial Hospital Research Institute Lodz Poland Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03619850 on ClinicalTrials.gov ↗ ← All trials in Mexico