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NCT03619850Phase 3RECRUITING

A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)

Study 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
Interventions / Drugs
FerumoxytolIron sucrose
View on ClinicalTrials.gov ↗
Sponsor
AMAG
AMAG Pharmaceuticals
Hematology
B78/100
Study Details
Enrollment129 participants
Primary Completion—
Lead SponsorAMAG Pharmaceuticals, Inc.
Data Retrieved2026-04-11 02:53:30.728000+00:00
What This Trial Means for Biotech Investors
Trial Phase Context

Phase 3 trials are pivotal studies with large patient populations (hundreds to thousands) designed to prove efficacy and safety for FDA submission. A successful Phase 3 readout is typically the last major hurdle before a New Drug Application (NDA) or BLA filing.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 129 participants
Sponsor Catalyst Profile

AMAG Pharmaceuticals (AMAG) is the sponsoring company for this trial. BiotechSign currently grades this company B (78/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

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