A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects

Launched by AMAG PHARMACEUTICALS, INC. · Mar 26, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called ferumoxytol for children and teenagers aged 2 to 17 who have iron deficiency anemia (IDA), a condition where the body lacks enough iron to produce healthy red blood cells. The aim is to see if ferumoxytol can help improve their condition, especially for those who have not had success with regular iron supplements. The study is open to both boys and girls and is currently recruiting participants.

To be eligible for the study, children must be between 2 and 17 years old and have IDA, which is defined by low hemoglobin levels and low iron in the body. They should also have had problems with oral iron treatment in the past or cannot take it for medical reasons. However, children with certain health issues, such as severe allergies to iron treatments or chronic kidney disease, cannot participate. If chosen to take part in the trial, participants will receive ferumoxytol and will be monitored to see how well it works in treating their anemia.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female 2 years to \<18 years of age at time of consent
• 2. Has IDA defined as:
• • 1. Hemoglobin (Hgb) \<11.0 g/dL AND
• 2. Any one or more of the following:
• • Transferrin saturation (TSAT) \<20%
• • ferritin \<100 ng/mL
• • 3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
• Exclusion Criteria:
• • 1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
• • 2. History of allergy to intravenous (IV) iron
• • 3. History of ≥2 clinically significant drug allergies
• • 4. Subjects with CKD (defined as eGFR of \<60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
• • 5. Low systolic blood pressure (BP) (age 1 to 9 years \<70 + \[age in years x 2\] mmHg, age 10 to 17 years \<90 mmHg)
• • 6. Hgb ≤7.0 g/dL
• • 7. Serum ferritin level \>600 ng/mL