The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department (ED-Heme FCM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Iron Deficiency Anemia Treatment; Iron Deficiency Anemia Secondary to IBD or Gastric Bypass; Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease; Iron Deficiency Anaemia Due to Dietary Causes; Iron Deficiency Anemias
• Intervention / Treatment: Drug: Ferrous Sulfate; Drug: Ferric Carboxymaltose (FCM)

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Manager, Clinical Research Programs; Phone Number: 714-509-3742; Email: shelby.shelton@choc.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1 year to 18 years of age
• Lab results indicative of anemia due to iron deficiency with Hb between 6.0 g/dL-10.0 g/dL for age and gender
• Patient is hemodynamically stable

Exclusion Criteria:

• Patients <1 year or > 18 years of age
• Patients with normal Hb or Hb <6 g/dL
• Overt Bleeding (excluding menstrual bleeding)
• Traumatic etiology for blood loss
• Malignancy
• Thrombocytopenia (platelets <100k)
• Active infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Newly diagnosed iron deficiency anemia; Participants receive oral iron supplementation	Drug: Ferrous Sulfate; Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation; Other Names: fer-in-sol; slow Fe
Experimental: Recurrent or refractory iron deficiency anemia; Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose	Drug: Ferric Carboxymaltose (FCM); Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose; Other Names: injectafer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to resolution of anemia	days to normalization of Hgb with treatment	6 months
Need for blood transfusions	Volume of blood transfused	6 months
Rates of Hospitalizations	Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia	6 months
Re-presentation rates	The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent in the Emergency department	Length of stay measured, in hours, in the emergency department.	6 months
Adverse reaction to interventional treatment	Side effects of treatment with iron	6 months
Treatment tolerability	Adherence to oral iron therapy	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in laboratory biomarkers	Associated changes in soluble transferrin receptor and reticulocyte hemoglobin equivalent during treatment for iron deficiency anemia	6 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Orange County

Study record dates

Study Major Dates

• Study Start (Estimated): January 31, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: anemia; Iron deficiency; ferric carboxymaltose
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Iron Metabolism Disorders; Anemia, Hypochromic; Nutritional and Metabolic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Anemia; Anemia, Iron-Deficiency; Organic Chemicals; Carbohydrates; Coordination Complexes; Polysaccharides; Glucans; Dextrans; Iron-Dextran Complex; ferrous sulfate; ferric carboxymaltose
• Other Study ID Numbers: 2510122; 16977021 (Other Grant/Funding Number: Pediatric Subspecialty Faculty Grant)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No