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Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease (FIRST)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01052779
First Posted: January 20, 2010
Last Update Posted: June 6, 2013
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.
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
  Purpose
The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD).

Condition Intervention Phase
Iron Deficiency Anemia Kidney Disease Drug: ferumoxytol Drug: iron sucrose Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicenter, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To evaluate the safety of IV ferumoxytol compared to IV iron sucrose

Secondary Outcome Measures:
  • To evaluate the efficacy of ferumoxytol as compared to iron sucrose by assessing changes in hemoglobin from Baseline to Week 5 [ Time Frame: 35 days ]

Enrollment: 162
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Iron Sucrose Arm
Safety and efficacy of IV iron sucrose for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD)
Drug: iron sucrose
IV infusion of iron sucrose for a total cumulative dose of 1.0 g
Active Comparator: Ferumoxytol arm
Safety and efficacy of intravenous (IV) ferumoxytol for the treatment of iron deficiency anemia (IDA) in subjects with chronic kidney disease (CKD).
Drug: ferumoxytol
IV injection of ferumoxytol for a total cumulative dose of 1.02 g
Other Name: Feraheme

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. An eGFR <60 mL/min or a diagnosis of CKD (eg, nephropathy, nephritis)
  3. Hemoglobin <11.0 g/dL
  4. TSAT <30%
  5. Hemodialysis subjects on maintenance dialysis for at least three months prior to screening and currently receiving dialysis three times per week
  6. 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 the study

Exclusion Criteria:

Key Exclusion Criteria include:

  1. History of allergy to IV iron
  2. Allergy to 2 or more classes of drugs
  3. Female subjects who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test
  4. Hemoglobin ≤7.0 g/dL
  5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an investigational agent not specified by this protocol during the study period
  6. Known causes of anemia other than iron deficiency (eg, hemolysis, vitamin B12 or folate deficiency, etc)
  Contacts and Locations
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): NCT01052779


Locations
United States, Massachusetts
AMAG Pharmaceuticals, Inc.
Lexington, Massachusetts, United States, 02421
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
Investigators
Study Director: William Strauss, MD, FACC AMAG Pharmaceuticals, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01052779     History of Changes
Other Study ID Numbers: FER-CKD-201
First Submitted: January 15, 2010
First Posted: January 20, 2010
Last Update Posted: June 6, 2013
Last Verified: May 2013

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
chronic kidney disease
Feraheme
ferumoxytol
iron sucrose
iron deficiency anemia (IDA)
chronic kidney disease (CKD)

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