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

January 15, 2010
May 29, 2013
March 2010
July 2011   (final data collection date for primary outcome measure)
To evaluate the safety of IV ferumoxytol compared to IV iron sucrose [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01052779 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Iron Deficiency
  • Anemia
  • Kidney Disease
  • Drug: ferumoxytol
    IV injection of ferumoxytol for a total cumulative dose of 1.02 g
    Other Name: Feraheme
  • Drug: iron sucrose
    IV infusion of iron sucrose for a total cumulative dose of 1.0 g
  • 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)
    Intervention: Drug: iron sucrose
  • 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).
    Intervention: Drug: ferumoxytol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
162
April 2012
July 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01052779
FER-CKD-201
No
AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
Not Provided
Study Director: William Strauss, MD, FACC AMAG Pharmaceuticals, Inc.
AMAG Pharmaceuticals, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP