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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:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01052779
First received: January 15, 2010
Last updated: May 29, 2013
Last verified: May 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01052779     History of Changes
Other Study ID Numbers: FER-CKD-201
Study First Received: January 15, 2010
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
India: Drugs Controller General of India
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on November 24, 2014