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A Phase IV Trial of Repeated Doses of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease on Hemodialysis (FACT)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc. Identifier:
First received: October 22, 2010
Last updated: September 19, 2016
Last verified: September 2016
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.

Condition Intervention Phase
The Treatment of Iron Deficiency Anemia in Patients With Chronic Kidney Disease
Drug: Ferumoxytol
Drug: Iron Sucrose
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Hemoglobin changes

Secondary Outcome Measures:
  • Changes in TSAT

Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Study Completion Date: November 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferumoxytol
Intravenous (IV) iron
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme
Active Comparator: IV Iron Sucrose
Intravenous (IV) iron
Drug: Iron Sucrose
IV Iron Sucrose
Other Name: Venofer


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01227616

United States, Massachusetts
AMAG Pharmaceuticals, Inc.
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Responsible Party: AMAG Pharmaceuticals, Inc. Identifier: NCT01227616     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-401
Study First Received: October 22, 2010
Last Updated: September 19, 2016

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia (IDA), Feraheme, ferumoxytol, chronic kidney disease (CKD), hemodialysis, magnetic resonance imaging (MRI)

Additional relevant MeSH terms:
Renal Insufficiency, Chronic
Kidney Diseases
Anemia, Iron-Deficiency
Deficiency Diseases
Renal Insufficiency
Urologic Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Nutrition Disorders
Ferric oxide, saccharated
Ferrosoferric Oxide
Ferric Compounds
Trace Elements
Growth Substances
Physiological Effects of Drugs
Parenteral Nutrition Solutions
Pharmaceutical Solutions processed this record on May 25, 2017