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:
Hemoglobin (Hgb) <11.0 g/dL AND
Any one or more of the following:
- Transferrin saturation (TSAT) <20%
- ferritin <100 ng/mL
- Documented history of unsatisfactory oral iron therapy or in whom oral iron cannotbe tolerated, or for whom oral iron is considered medically inappropriate
Exclusion
Exclusion Criteria:
Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
History of allergy to intravenous (IV) iron
History of ≥2 clinically significant drug allergies
Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement forchronic hemodialysis or peritoneal dialysis during Screening)
Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg,age 10 to 17 years <90 mmHg)
Hgb ≤7.0 g/dL
Serum ferritin level >600 ng/mL
Study Design
Study Description
Connect with a study center
JSC Saules seimos medicinos centras
Kaunas,
LithuaniaSite Not Available
Klaipeda Children's Hospital
Klaipėda,
LithuaniaSite Not Available
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius,
LithuaniaSite Not Available
Osrodek Badan Klinicznych In Vivo sp. z o.o.
Bydgoszcz,
PolandSite Not Available
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
Debica,
PolandSite Not Available
Pro Familia Altera Sp. z o.o.
Katowice,
PolandSite Not Available
Korczowski Bartosz, Gabinet Lekarski
Rzeszów,
PolandSite Not Available
Centrum Zdrowia MDM
Warsaw,
PolandSite Not Available
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wrocław,
PolandSite Not Available
Arkansas Children's Hospital
Little Rock, Arkansas 72202
United StatesSite Not Available
University of Florida
Gainesville, Florida 32608
United StatesSite Not Available
Biomedical Research LLC
Miami, Florida 33184
United StatesActive - Recruiting
Optimus U Corporation
Miami, Florida 33125
United StatesActive - Recruiting
Gwinnett Research Institute
Buford, Georgia 30519
United StatesSite Not Available
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts 02451
United StatesSite Not Available
Sun Research Institute
San Antonio, Texas 78215
United StatesActive - Recruiting
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