Phase
Condition
Anemia
Treatment
Iron sucrose
Ferumoxytol
Clinical Study ID
Ages 2-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female 2 years to <18 years of age at time of consent
Has IDA defined as: a) hemoglobin <12.0 g/dL and b) with either transferrinsaturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk ofdevelopment of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2months 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., persistentalbuminuria, abnormal urine sediment, electrolyte and other abnormalities dueto tubular disorders for > 3 months.
For patients other than hemodialysis dependent CKD patients, documented history ofunsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or forwhom oral iron is considered medically inappropriate
All subjects (female and male) of childbearing potential who are sexually activemust be on an effective method of birth control for at least 1 month prior to Day 1Dosing and agree to remain on birth control until completion of the study
Exclusion
Exclusion Criteria:
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 10-17years <90 mmHg)
Hemoglobin ≤7.0 g/dL
Serum ferritin level >600 ng/mL
Study Design
Study Description
Connect with a study center
Semmelweis Egyetem - Altalanos Orvostudomanyi Kar (SE AOK) - I. sz. Gyermekgyogyaszati Klinika
Budapest,
HungaryActive - Recruiting
University Of Szeged
Szeged,
HungaryActive - Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas,
LithuaniaSite Not Available
Klaipeda Children's Hospital
Klaipėda,
LithuaniaSite Not Available
Vsl Vilniaus Universiteto Vaiku Ligonine (VUVL) (Vilnius University Children's Hospital)
Vilnius,
LithuaniaSite Not Available
Instituto Mexicano De Trasplantes S.C
Cuernavaca,
MexicoActive - Recruiting
JM Research, SC
Cuernavaca,
MexicoSite Not Available
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara,
MexicoActive - Recruiting
Instituto Nacional de Pediatria (INP) (National Institute of Pediatrics)
Mexico City,
MexicoActive - Recruiting
Uniwersytecki Szpital Kliniczny Im. Zamenhofa w Bialystoku
Białystok,
PolandSite Not Available
Specjalistyczne Gabinety Sp. z o.o
Kraków,
PolandSite Not Available
University Children Hospital
Kraków,
PolandSite Not Available
Polish Mother's Memorial Hospital Research Institute
Łódź,
PolandSite Not Available
Memorial Healthcare System
Hollywood, Florida 33021
United StatesSite Not Available
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts 02451
United StatesSite Not Available
Wayne State University
Detroit, Michigan 48201
United StatesSite Not Available
Children's Mercy Hospital
Kansas City, Missouri 64108
United StatesActive - Recruiting
Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)
Bronx, New York 10467
United StatesActive - Recruiting
The Feinstein Institute Medical Research Organization of Northwell Health, Inc.
Lake Success, New York 11042
United StatesSite Not Available
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York 10029
United StatesSite Not Available
Akron Nephrology Associates, Inc.
Akron, Ohio 44302
United StatesActive - Recruiting
West Virginia University
Morgantown, West Virginia 26506
United StatesActive - Recruiting
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