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A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)

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ClinicalTrials.gov Identifier: NCT02694978
Recruitment Status : Completed
First Posted : March 1, 2016
Results First Posted : June 11, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
AMAG Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE February 8, 2016
First Posted Date  ICMJE March 1, 2016
Results First Submitted Date  ICMJE March 26, 2018
Results First Posted Date  ICMJE June 11, 2018
Last Update Posted Date June 11, 2018
Actual Study Start Date  ICMJE February 29, 2016
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension [ Time Frame: Day 1 (after first dosing) through Week 5 ]
All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). Hypotension is defined as a >30% drop in systolic blood pressure from baseline or decrease of >20 mmHg for systolic blood pressure. Statistical analysis was only performed on composite data. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2016)
Assessing the incidence of moderate to severe hypersensitivity reactions including anaphylaxis and of moderate to severe hypotension [ Time Frame: 9 weeks ]
To assess the incidence of moderate to severe hypersensitivity reactions, including anaphylaxis, and of moderate to severe hypotension with ferumoxytol as compared to FCM. Signs and symptoms potentially representing hypersensitivity will be recorded and adjudicated by a blinded Clinical Events Committee (CEC). Anaphylaxis will be categorized based on the criteria of Sampson et al, 2006. Hypotension is defined as a 30% drop in systolic blood pressure.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2018)
  • Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death [ Time Frame: Day 1 (after first dosing) through Week 5 ]
    All IV iron formulations carry some risk of serious hypersensitivity reactions or anaphylaxis. Signs and symptoms potentially representing hypersensitivity were recorded and adjudicated by a blinded Clinical Events Committee (CEC). A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
  • Mean Change In Hemoglobin From Baseline To Week 5 [ Time Frame: Baseline (Day 1), Week 5 ]
    Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
  • Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5 [ Time Frame: Baseline (Day 1), Week 5 ]
    Mean change in hemoglobin per g of iron administered from Baseline (Day 1) to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline). Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 24, 2016)
Assessing the composite safety endpoint of moderate to severe hypersensitivity reactions, serious cardiovascular events and death. [ Time Frame: 9 weeks ]
To assess the incidence of the composite safety endpoint of moderate to severe hypersensitivity reactions, serious cardiovascular events, and death for ferumoxytol as compared to FCM. Signs and symptoms potentially representing hypersensitivity will be recorded and adjudicated by a blinded Clinical Events Committee (CEC). Anaphylaxis will be categorized based on the criteria of Sampson et al, 2006.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Official Title  ICMJE A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Brief Summary To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • Drug: Ferumoxytol
    Other Name: Feraheme
  • Drug: FCM
    Other Name: Injectafer, Ferinject
Study Arms  ICMJE
  • Experimental: Ferumoxytol
    Participants received an IV infusion of ferumoxytol 510 milligram (mg) diluted (17 milliliter [mL]) in 233 mL 0.9% sodium chloride injection, United States Pharmacopeia (USP) (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.020 g.
    Intervention: Drug: Ferumoxytol
  • Active Comparator: FCM
    Participants received an IV infusion of FCM 750 mg diluted (15 mL) in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes with a second dose 7-8 days after the first dose, for a total cumulative dose of 1.500 g.
    Intervention: Drug: FCM
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 10, 2018)
2014
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2016)
2000
Actual Study Completion Date  ICMJE July 17, 2017
Actual Primary Completion Date January 16, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria include:

  • Participants with IDA and in whom IV iron treatment is indicated and defined as:

    • Participants with documented hemoglobin <12.0 g per deciliter (dL) for females and <14.0 g/dL for males within 60 days of dosing And
    • Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
  • Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
  • All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

  • Known hypersensitivity reaction to any component of ferumoxytol or FCM
  • History of allergy to an IV iron
  • History of multiple drug allergies
  • Participants with dialysis-dependent chronic kidney disease
  • Hemoglobin ≤7.0 g/dL
  • Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Hungary,   Latvia,   Lithuania,   Poland,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02694978
Other Study ID Numbers  ICMJE AMAG-FER-IDA-304
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party AMAG Pharmaceuticals, Inc.
Study Sponsor  ICMJE AMAG Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AMAG Pharmaceuticals, Inc.
Verification Date May 2018

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