Recruiting
Phase 3

Ferumoxytol

Sponsor:

AMAG Pharmaceuticals, Inc.

Code:

NCT03893045

Conditions

Iron Deficiency Anemia

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

ferumoxytol

Iron sucrose

Study Details

Brief 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. 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).

Conditions

Iron Deficiency Anemia

Study ID

NCT03893045

Start date

Sep 18, 2019

Status verified date

Apr, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female 2 years to <18 years of age at time of consent
2. Has IDA defined as:

1. Hemoglobin (Hgb) <11.0 g/dL AND
2. Any one or more of the following:

  • Transferrin saturation (TSAT) <20%
  • ferritin <100 ng/mL
3. Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of ferumoxytol or iron sucrose
2. History of allergy to intravenous (IV) iron
3. History of ≥2 clinically significant drug allergies
4. Subjects with CKD (defined as eGFR of <60 mL/min/1.73 m2 or a requirement for chronic hemodialysis or peritoneal dialysis during Screening)
5. Low systolic blood pressure (BP) (age 1 to 9 years <70 + \[age in years x 2\] mmHg, age 10 to 17 years <90 mmHg)
6. Hgb ≤7.0 g/dL
7. Serum ferritin level >600 ng/mL

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ferumoxytol

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.

active comparator: Iron sucrose

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)

Interventions

ferumoxytol

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 sucrose

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).

Primary outcome measure

  • Change in Hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ]

Central Contacts and Locations

Central contacts

Clinical Trial Interest

1-877-374 -4177CTInterest@covispharma.com

Locations

Optimus U Corporation

Recruiting

Miami, Florida, United States, 33125

Biomedical Research LLC

Recruiting

Miami, Florida, United States, 33184

Sun Research Institute

Recruiting

San Antonio, Texas, United States, 78215

More Information

Sponsor

AMAG Pharmaceuticals, Inc.

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

  • IDA
  • anemia
  • pediatrics
  • ferumoxytol
  • iron sucrose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc. on 2026-04-17.