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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AMAG Pharmaceuticals, Inc.
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Ferrosoferric Oxide; Iron

Criteria

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