Iron Deficiency AnemiaPhase 3NCT03893045
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
A Phase 3 study testing ferumoxytol and Iron sucrose in people with Iron Deficiency Anemia, run by AMAG Pharmaceuticals, Inc. at 15 sites in 3 countries.
Trial summary
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to <18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Iron Deficiency Anemia
- What is being tested?
- ferumoxytol and Iron sucrose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 18 Sep 2019to Oct 2026
- Phase
- Phase 3
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female 2 years to <18 years of age at time of consent
- Has IDA defined as:
- Hemoglobin (Hgb) <11.0 g/dL AND
- Any one or more of the following:
- Transferrin saturation (TSAT) <20%
- ferritin <100 ng/mL
- Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
Who cannot join
- Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
- History of allergy to intravenous (IV) iron
- History of ≥2 clinically significant drug allergies
- Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
- Low systolic blood pressure (BP) (age 1 to 9 years <70 + [age in years x 2] mmHg, age 10 to 17 years <90 mmHg)
- Hgb ≤7.0 g/dL
- Serum ferritin level >600 ng/mL
Trial locations and contacts
15 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
15 sites in 3 countries
United States6 sites, 6 recruiting
- Not yet recruiting
Gwinnett Research Institute
Buford, Georgia, 30519
- Not yet recruiting
University of Florida
Gainesville, Florida, 32608
- Not yet recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
- Recruiting
Optimus U Corporation
Miami, Florida, 33125
- Recruiting
Biomedical Research LLC
Miami, Florida, 33184
- Recruiting
Sun Research Institute
San Antonio, Texas, 78215
Poland6 sites, 6 recruiting
- Not yet recruiting
Osrodek Badan Klinicznych In Vivo sp. z o.o.
Bydgoszcz
- Not yet recruiting
Prywatny Gabinet Lekarski Dr N. med. Jerzy Brzostek
Dębica
- Not yet recruiting
Pro Familia Altera Sp. z o.o.
Katowice
- Not yet recruiting
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
- Not yet recruiting
Centrum Zdrowia MDM
Warsaw
- Not yet recruiting
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
Wroclaw
Lithuania3 sites, 3 recruiting
- Not yet recruiting
JSC Saules seimos medicinos centras
Kaunas
- Not yet recruiting
Klaipeda Children's Hospital
Klaipėda
- Not yet recruiting
Children's Hospital-Affiliate of Vilnius University Hospital Santariskiu Klinikos
Vilnius
About this study
Official title: A Phase 3, Randomized, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to <18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA. This study allows for enrollment of subjects with IDA regardless of etiology, except for CKD subjects (pediatric CKD subjects are being studied in a separate ferumoxytol protocol).
Read the detailed description
Subjects will be randomized to treatment in a 2:1 ratio (ferumoxytol: iron sucrose) and stratified by age group (2 to <6 years; 6 to <12 years; and 12 to <18 years). Subjects will receive one of the following treatment regimens:
- Ferumoxytol: 7 mg Fe/kg IV (maximum 510 mg/dose) x 2 doses, the first dose administered on Day 1 and the second 2 to 8 days later.
OR
- Iron sucrose (Venofer®): 4 mg Fe/kg IV (maximum 200 mg/dose) x 5 doses, the first dose on Day 1 and subsequent doses administered at least once per week and up to 3 times/week. All subjects will be monitored at the study site through at least 1 hour after the completion of each infusion of study drug. Assessment of blood Hgb concentrations, adverse events, and other safety assessments will be performed through study Week 5.
- Conditions
- Iron Deficiency Anemia
- Being tested
- ferumoxytol, Iron sucrose
- Keywords
- IDA, anemia, pediatrics, ferumoxytol, iron sucrose
- Medical subject headings
- Anemia, Iron-Deficiency, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ferumoxytolDrug
Also called Feraheme
Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
Iron sucroseDrug
Also called Venofer
Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxytol | Experimental | Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution. Receives: Drug: ferumoxytol |
| Iron sucrose | Active comparator | Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL) Receives: Drug: Iron sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin from Baseline to Week 5
Proportion of subjects achieving a change in hemoglobin from Baseline to Week 5
Measured: 35 days
Secondary outcomes (2)
Incidence of Treatment Emergent Adverse Events
Incidence of Treatment Emergent Adverse Events
Measured: 49 days
Incidence of adverse events of special interest (AESI)
Incidence of adverse events of special interest (AESI) (hypotension and hypersensitivity)
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start18 Sep 2019
- Primary completionJul 2026 (estimated)
- Study completionOct 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 AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AMAG Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893045
- Sponsor's protocol ID
- AMAG-FER-IDA-352
- Status last verified
- Apr 2026
- First submitted
- 22 Mar 2019
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No