Last updated 56 days ago

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)

129 patients around the world
Available in Mexico
This is a Phase 3, randomized, open-label, multicenter, study of the safety (compared to iron sucrose), efficacy, and PK/PD of ferumoxytol (7.0 mg Fe/kg x 2 [max 510 mg/dose]) in pediatric subjects with iron deficiency anemia (IDA) and CKD. There will be a total of approximately 125 subjects randomized to treatment in a 2:1 ratio to either ferumoxytol or iron sucrose. Total subject participation in the study will be up to 7 weeks, which includes a 2-week Screening Period and a 5-week Treatment Period. Subjects receive the following: • Two IV infusions of ferumoxytol 7.0 mg Fe/kg (max 510 mg/dose), the first administered on Day 1 and the second 2-8 days later OR • Iron sucrose (Venofer®): For Hemodialysis Dependent (HDD) patients: 2 mg Fe/kg, administered on consecutive dialysis sessions, for 10 doses (max 100mg/dose with a total max treatment course of 1000mg) For Non-hemodialysis Dependent (NDD) or Peritoneal Dialysis De pendent(PDD) patients: 4 mg Fe/kg, administered up to 3 times/week, for 5 doses (max 200mg/dose with a total max treatment course of 1000mg).
AMAG Pharmaceuticals, Inc.
2Research sites
129Patients around the world
This study is for people with
Renal disease
Chronic kidney disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
Sites
Hospital Civil de Guadalajara Fray Antonio Alcalde
Recruiting
Guadalajara, Jalisco, Mexico, 44280
Instituto Nacional de Pediatría - México
Recruiting
Avenida de los Insurgentes Sur 3700 letra C, Coyoacán, Insurgentes, Cuicuilco
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