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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Ferric Carboxymaltose in the Treatment of Pediatric Iron Deficiency Anemia in the Emergency Department
- ClinicalTrials.gov ID
- NCT07414199
- Acronym / sponsor ID
- ED-Heme FCM / 2510122
- 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
- Keywords
- Iron deficiency, anemia, ferric carboxymaltose
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Children's Hospital of Orange CountyUniversity, hospital or other
- Study start
- 31 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Newly diagnosed iron deficiency anemia | Active comparator | Drug: Ferrous SulfateParticipants receive oral iron supplementation |
| Recurrent or refractory iron deficiency anemia | Experimental | Drug: Ferric Carboxymaltose (FCM)Participants are randomized to receive oral iron supplementation or IV Ferric carboxymaltose |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferric Carboxymaltose (FCM)Also: injectaferParticipants with recurrent or refractory iron deficiency anemia will be randomized to receive oral iron supplementation or IV Ferric carboxymaltose | Drug | Recurrent or refractory iron deficiency anemia |
| Ferrous SulfateAlso: fer-in-sol, slow FeNewly diagnosed iron deficiency anemia participants will receive oral iron supplementation | Drug | Newly diagnosed iron deficiency anemia |
Primary outcome
Time to resolution of anemia
Time frame: 6 months
days to normalization of Hgb with treatment
Need for blood transfusions
Time frame: 6 months
Volume of blood transfused
Rates of Hospitalizations
Time frame: 6 months
Number of patients with iron deficiency anemia enrolled on study and hospitalized due to their anemia
Re-presentation rates
Time frame: 6 months
The number of patients enrolled on the study that re-present to the ED for ongoing care of their anemia
3 secondary outcomes
Time spent in the Emergency department
Time frame: 6 months
Adverse reaction to interventional treatment
Time frame: 6 months
Treatment tolerability
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Clinical Research Programs (714-509-3742, shelby.shelton@choc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of anemia (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.