NCT07414199

Brief 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. 1.examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort.
  2. 2.determine the feasibility of IV FCM in the pediatric ED.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
8mo left

Started Jan 2026

Shorter than P25 for phase_4

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress29%
Jan 2026Dec 2026

First Submitted

Initial submission to the registry

December 9, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

January 31, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

December 9, 2025

Last Update Submit

February 10, 2026

Conditions

Iron Deficiency Anaemia Due to Dietary CausesIron Deficiency Anemia TreatmentIron Deficiency AnemiasIron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseaseIron Deficiency Anemia Secondary to IBD or Gastric Bypass

Keywords

Iron deficiencyanemiaferric carboxymaltose

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Time spent in the Emergency department

    6 months

  • Adverse reaction to interventional treatment

    6 months

  • Treatment tolerability

    6 months

Other Outcomes (1)

  • Changes in laboratory biomarkers

    6 months

Study Arms (2)

Newly diagnosed iron deficiency anemia

ACTIVE COMPARATOR

Participants receive oral iron supplementation

Drug: Ferrous Sulfate

Recurrent or refractory iron deficiency anemia

EXPERIMENTAL

Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose

Drug: Ferric Carboxymaltose (FCM)

Interventions

Ferric Carboxymaltose (FCM)DRUG

Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose

Also known as: injectafer
Recurrent or refractory iron deficiency anemia
Ferrous SulfateDRUG

Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation

Also known as: fer-in-sol, slow Fe
Newly diagnosed iron deficiency anemia

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron DeficienciesAnemia

Interventions

ferric carboxymaltoseferrous sulfateIron-Dextran Complex

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsDextransGlucansPolysaccharidesCarbohydrates

Central Study Contacts

Manager, Clinical Research Programs

CONTACT

714-509-3742shelby.shelton@choc.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician Attending

Study Record Dates

First Submitted

December 9, 2025

First Posted

February 17, 2026

Study Start

January 31, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share