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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01227616
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief 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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 296 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Actual Study Start Date : August 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Hemoglobin Changes [ Time Frame: Up to 6 treatment periods (5 weeks per treatment period) ]
    Changes in the mean hemoglobin between Baseline and Week 5 for ferumoxytol and iron sucrose in each treatment period.


Secondary Outcome Measures :
  1. Changes in Transferrin Saturation (TSAT) [ Time Frame: Up to 6 treatment periods (5 weeks per treatment period) ]
    Mean change in TSAT from TP Baseline to Week 5 for each TP

  2. Proportion of Subjects With an Increase in Hemoglobin of ≥1.0 g/dL at Any Time From TP Baseline to Week 5 for Each TP [ Time Frame: Up to 6 treatment periods (5 weeks per treatment period) ]
    Number of participants in each Treatment Period (TP)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227616


Locations
Show Show 43 study locations
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01227616    
Other Study ID Numbers: AMAG-FER-CKD-401
First Posted: October 25, 2010    Key Record Dates
Results First Posted: July 19, 2019
Last Update Posted: July 19, 2019
Last Verified: June 2019
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:
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Kidney Diseases
Renal Insufficiency, Chronic
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Urologic Diseases
Renal Insufficiency
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Ferrosoferric Oxide
Ferric Oxide, Saccharated
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions