Recruiting
Phase 3

Ferumoxytol vs. Iron Sucrose

Sponsor:

AMAG Pharmaceuticals, Inc.

Code:

NCT03619850

Conditions

Chronic Kidney Disease; Iron Deficiency Anemia

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Ferumoxytol

Iron sucrose

Study Details

Brief summary:

Primary Objectives:

To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA

Secondary Objective:

To determine the single-dose pharmacokinetics (PK) and pharmacodynamics (PD) profile of ferumoxytol in pediatric subjects.

Conditions

Chronic Kidney Disease; Iron Deficiency Anemia

Study ID

NCT03619850

Start date

Aug 13, 2018

Status verified date

Aug, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 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: a) hemoglobin <12.0 g/dL and b) with either transferrin saturation (TSAT) <40% or ferritin <100 ng/mL; or considered to be at risk of development of IDA, i.e., TSAT<20% with falling hemoglobin during the preceding 2 months and a history of hemoglobin <12 g/dL
3. Has Chronic Kidney Disease defined as one of the following:

1. on chronic hemodialysis;
2. receiving chronic peritoneal dialysis;
3. estimated glomerular filtration rate (eGFR) of <60 mL/min/1.73 m2;
4. has evidence of structural and/or functional abnormalities e.g., persistent albuminuria, abnormal urine sediment, electrolyte and other abnormalities due to tubular disorders for > 3 months.
4. For patients other than hemodialysis dependent CKD patients, documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate
5. All subjects (female and male) of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to Day 1 Dosing and agree to remain on birth control until completion of the study

Exclusion Criteria:

1. Known hypersensitivity reaction to any component of ferumoxytol and iron sucrose
2. History of allergy to intravenous (IV) iron
3. History of multiple drug allergies (>2)
4. Low systolic blood pressure (Age 1-9 years <70 + \[age in years x 2\] mmHg, Age 10-17 years <90 mmHg)
5. Hemoglobin ≤7.0 g/dL
6. Serum ferritin level >600 ng/mL

Study Design

Enrollment

129 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ferumoxytol

active comparator: Iron sucrose

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

  • Hemoglobin change of at least 0.5 g/dL from Baseline to Week 5 [ Time Frame: 35 days ]

Central Contacts and Locations

Central contacts

Locations

Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

Montefiore Medical Center (MMC) - The Children's Hospital at Montefiore (CHAM)

Recruiting

The Bronx, New York, United States, 10467

Akron Nephrology Associates, Inc.

Recruiting

Akron, Ohio, United States, 44302

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

More Information

Sponsor

AMAG Pharmaceuticals, Inc.

Last update posted

Apr 17, 2026

Last verified

Aug, 2025

Keywords

  • Iron deficiency anemia (IDA)
  • chronic kidney disease (CKD)
  • pediatrics
  • ferumoxytol
  • iron sucrose
  • Feraheme
  • Venofer

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.