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Trial record 98 of 380 for:    FERRIC CATION

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.

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).

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferumoxytol Drug: FCM Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2014 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Actual Study Start Date : February 29, 2016
Actual Primary Completion Date : January 16, 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Ferumoxytol
Other Name: Feraheme

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.
Drug: FCM
Other Name: Injectafer, Ferinject




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.



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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

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)

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): NCT02694978


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Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02694978     History of Changes
Other Study ID Numbers: AMAG-FER-IDA-304
First Posted: March 1, 2016    Key Record Dates
Results First Posted: June 11, 2018
Last Update Posted: June 11, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by AMAG Pharmaceuticals, Inc.:
iron deficiency anemia
IDA
ferumoxytol
ferric carboxymaltose
FCM
Injectafer
Feraheme
Ferinject
Additional relevant MeSH terms:
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Ferric Compounds
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Ferrosoferric Oxide
Hematinics
Parenteral Nutrition Solutions
Pharmaceutical Solutions