Overview

A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease

Status:
Terminated

Trial end date:
2015-04-24

Target enrollment:
0

Participant gender:
All

Summary

Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with ferumoxytol.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

AMAG Pharmaceuticals, Inc.

Treatments:

Ferrosoferric Oxide

Criteria

Key Inclusion Criteria include:

1. Participants who had completed participation in the combined AMAG-FER-CKD-251 and
AMAG-FER-CKD-252 studies within 4 weeks of screening

2. Female participants of childbearing potential who are sexually active must be on an
effective method of birth control and agree to remain on birth control until
completion of participation in the study

3. Participant and/or legal guardian is capable of understanding and complying with the
protocol requirements and is available for the duration of the study

Key Exclusion Criteria include:

1. Experienced a serious adverse event related to IV iron therapy in the combined
AMAG-FER-CKD-251 and AMAG-FER- CKD-252 studies

2. Hemoglobin level ≤7 g/dL