Overview

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)

Status:
Recruiting
Trial end date:
2022-01-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 3
Details
Lead Sponsor:
AMAG Pharmaceuticals, Inc.
Treatments:
Ferric Compounds
Ferric Oxide, Saccharated
Ferrosoferric Oxide
Iron