Overview

This trial is active, not recruiting.

Condition the treatment of iron deficiency anemia in patients with chronic kidney disease
Treatments ferumoxytol, iron sucrose
Phase phase 4
Sponsor AMAG Pharmaceuticals, Inc.
Start date May 2013
End date February 2016
Trial size 300 participants
Trial identifier NCT01227616, AMAG-FER-CKD-401

Summary

The objectives of this study are to compare the efficacy and safety of repeat doses of intravenous (IV) ferumoxytol with IV iron sucrose for the treatment of IDA in subjects with hemodialysis-dependent CKD.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Intravenous (IV) iron
ferumoxytol Feraheme
IV Ferumoxytol
(Active Comparator)
Intravenous (IV) iron
iron sucrose Venofer
IV Iron Sucrose

Primary Outcomes

Measure
Hemoglobin changes
time frame:

Secondary Outcomes

Measure
Changes in TSAT
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria include: 1. Males and females ≥18 years of age 2. Diagnosis of CKD 3. Subjects on dialysis must have been on dialysis for at least 3 months prior to screening 4. Female subjects of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study Key Exclusion Criteria include: 1. History of allergy to either oral or IV iron 2. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test 3. Parenteral iron therapy within 30 days prior to screening or red blood cell (RBC)/whole blood transfusion within 14 days prior to screening or planned during the study

Additional Information

Official title Ferumoxytol for Anemia of CKD Trial (FACT): A Phase IV, Open-Label, Multicenter Trial, With MRI Substudy, of Repeated Doses of Ferumoxytol Compared With Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA) in Chronic Kidney Disease (CKD) Patients on Hemodialysis
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by AMAG Pharmaceuticals, Inc..