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Safety and Efficacy of Ferimoxytol vs. Iron Sucrose

Safety and Efficacy of Ferimoxytol in Pediatric Anemia Patients

Description:

To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric chronic kidney disease (CKD) subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA.

For complete study information please visit Clinicaltrials.gov

Who May Qualify?:
  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:
    • 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., 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
Who Does Not Qualify:
  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
  7. Children younger than 2 or over 17 years
Interested in participating?
We are currently recruiting
Study Sponsor:

AMAG Pharmaceuticals

Full IRB Study Title:
A Phase 3, Randomized, Open-Label, Multicenter 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 Protocol No: AMAG-FER-CKD-354
IRB Study ID:
1248983
If you are interested in this study or have questions about your child's eligibility, please contact:
Rebecca D. Considine Research Institute, 330-543-3193 or email research@akronchildrens.org
Lead Investigator
Rupesh Raina, MD, FACP, FAAP

Pediatric Nephrologist
Pediatric NephrologyPediatric Hypertension ClinicKidney Stone Clinic