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

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ClinicalTrials.gov Identifier: NCT01052779
Recruitment Status : Completed
First Posted : January 20, 2010
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Brief Summary:
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 participants with chronic kidney disease (CKD).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Kidney Disease Drug: Ferumoxytol Drug: Iron Sucrose Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
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
Actual Study Start Date : March 1, 2010
Actual Primary Completion Date : July 19, 2011
Actual Study Completion Date : April 19, 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ferumoxytol
Participants received an IV injection of ferumoxytol (510 milligrams [mg], 17 milliliters [mL]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).
Drug: Ferumoxytol
IV Ferumoxytol
Other Name: Feraheme

Active Comparator: Iron Sucrose

Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

Drug: Iron Sucrose
IV Iron Sucrose
Other Name: Venofer




Primary Outcome Measures :
  1. Mean Change In Hemoglobin From Baseline (Day 1) To Week 5 [ Time Frame: Baseline (Day 1), Week 5 ]

    The change in hemoglobin from Baseline (Day 1) to Week 5 was calculated for each participant as:

    Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline)

    The least squares mean, with standard error, is reported as g/deciliter (dL). Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug). The screening hemoglobin value was used for any participants with missing Baseline (Day 1) hemoglobin. Analysis used last observed carried forward (LOCF) imputation methods for missing values for the ITT population. Sensitivity analyses were performed without imputation for missing data and with the Markov chain Monte Carlo method.


  2. Percentage Of Participants With An Increase In Hemoglobin ≥1.0 g/dL From Day 1 (Baseline) To Week 5 [ Time Frame: Baseline (Day 1) and up to Week 5 ]
    The percentage of participants who achieved a ≥1.0 g/dL increase in hemoglobin at any time from Baseline (Day 1) up to Week 5 by treatment group is presented by study visit. Baseline hemoglobin for each participant was the Day 1 hemoglobin value (prior to injection of the study drug).



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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

Inclusion Criteria:

Key Inclusion Criteria include:

  1. Males and females ≥18 years of age
  2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)
  3. Hemoglobin <11.0 g/deciliter (dL)
  4. Transferrin saturation <30%
  5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week
  6. Female participants 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 participants 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 unspecified investigational agent during the study period
  6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

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


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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.

Publications:
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
2009-015630-30 ( EudraCT Number )
First Posted: January 20, 2010    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: May 2018

Keywords provided by AMAG Pharmaceuticals, Inc.:
Iron deficiency anemia
Chronic kidney disease
Feraheme
Ferumoxytol
Iron sucrose
IDA
CKD
Venofer

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