Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseasePhase 4ED-Heme FCMNCT07414199
The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
A Phase 4 study testing Ferric Carboxymaltose (FCM) and Ferrous Sulfate in people with Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease and Iron Deficiency Anaemia Due to Dietary Causes, run by Children's Hospital of Orange County.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney Disease, Iron Deficiency Anaemia Due to Dietary Causes, Iron Deficiency Anemia Treatment
- What is being tested?
- Ferric Carboxymaltose (FCM) and Ferrous Sulfate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2026to 31 Dec 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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:
Read more
- examine and compare healthcare utilization and clinical outcomes of IV FCM use in the pediatric ED compared to historical cohort.
- 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
- Being tested
- Ferric Carboxymaltose (FCM), Ferrous Sulfate
- Keywords
- Iron deficiency, anemia, ferric carboxymaltose
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferric Carboxymaltose (FCM)Drug
Also called injectafer
Participants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose
Ferrous SulfateDrug
Also called fer-in-sol, slow Fe
Newly diagnosed iron deficiency anemia participants will receive oral iron supplementation
| Study group | Role | What they receive |
|---|---|---|
| Newly diagnosed iron deficiency anemia | Active comparator | Participants receive oral iron supplementation Receives: Drug: Ferrous Sulfate |
| Recurrent or refractory iron deficiency anemia | Experimental | Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose Receives: Drug: Ferric Carboxymaltose (FCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of anemia
days to normalization of Hgb with treatment
Measured: 6 months
Need for blood transfusions
Volume of blood transfused
Measured: 6 months
Rates of Hospitalizations
Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia
Measured: 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
Measured: 6 months
Secondary outcomes (3)
Time spent in the Emergency department
Length of stay measured, in hours, in the emergency department.
Measured: 6 months
Adverse reaction to interventional treatment
Side effects of treatment with iron
Measured: 6 months
Treatment tolerability
Adherence to oral iron therapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start31 Jan 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron Deficiency Anemia Associated With Non-Dialysis Dependent Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Orange County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maritza Ruiz, Children's Hospital of Orange County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414199
- Sponsor's protocol ID
- 2510122
- Other IDs
- 16977021
- Acronym
- ED-Heme FCM
- Status last verified
- Feb 2026
- First submitted
- 9 Dec 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No