NCT07414199

The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Children's Hospital of Orange County · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this project is to assess the feasibility, clinical effectiveness, and cost-effectiveness of IV iron therapy using ferric carboxymaltose (FCM) as a treatment for pediatric patients with iron deficiency anemia (IDA) in the emergency department (ED). The primary objectives are to: 1. examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort. 2. determine the feasibility of IV FCM in the pediatric ED. A secondary objective of this study is to evaluate if additional laboratory markers such as soluble transferrin receptor (sTfR) or reticulocyte hemoglobin equivalent can serve as potential surrogate markers for diagnosing and monitoring treatment response of IDA between oral iron and IV FCM. By evaluating clinical outcomes such as the time to resolution of anemia, hospitalization rates and need for PRBC transfusion, assessing the feasibility of FCM implementation, and secondarily exploring potential adjunct markers for monitoring IDA, this study aims to fill the current research gap and potentially revolutionize management of IDA in pediatric emergency care.

Conditions

• Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease
• Iron Deficiency Anaemia Due to Dietary Causes
• Iron Deficiency Anemia Treatment
• Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
• Iron Deficiency Anemias

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose
DRUG	Ferrous Sulfate	Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation

Timeline

• Start date: 2026-01-31
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17

Regulatory

• FDA-regulated drug study