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 currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by AMAG Pharmaceuticals, Inc.
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01227616
First received: October 22, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in TSAT [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: January 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227616

Contacts
Contact: William Strauss, MD 617-498-7696 factstudyinfo@amagpharma.com

Locations
United States, Massachusetts
AMAG Pharmaceuticals, Inc. Recruiting
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01227616     History of Changes
Other Study ID Numbers: AMAG-FER-CKD-401
Study First Received: October 22, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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:
Anemia, Iron-Deficiency
Iron Metabolism Disorders
Anemia
Kidney Diseases
Deficiency Diseases
Renal Insufficiency, Chronic
Hematologic Diseases
Urologic Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Metabolic Diseases
Renal Insufficiency
Ferric oxide, saccharated
Ferric Compounds
Ferrosoferric Oxide
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Parenteral Nutrition Solutions
Pharmaceutical Solutions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 27, 2014