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Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

Primary Purpose

Iron Deficiency Anemia (IDA)

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Injectafer
SOC
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia (IDA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects ≥ 18 years of age and able to give informed consent.
  • Iron deficiency is the primary etiology of anemia.
  • If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days.
  • Doses of potential myelosuppressive medications have been stable for at least 30 days.
  • Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing.

Exclusion Criteria:

  • Hypersensitivity reaction to any component of Injectafer.
  • Requires dialysis for treatment of chronic kidney disease (CKD).
  • No evidence of iron deficiency.
  • During the 10 day period prior to screening has been treated with intravenous iron.
  • During the 30 day period prior to screening has been treated with a red red blood cell transfusion.
  • Any non-viral infection.
  • Known positive hepatitis with evidence of active disease.
  • Received an investigational drug within 30 days of screening.
  • Alcohol or drug abuse within the past 6 months.
  • Hemochromatosis or other iron storage disorders.
  • Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
  • Pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential).
  • Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Injectafer

    IV Iron Standard of Care (SOC)

    Arm Description

    2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.

    At a dose and administration regimen as determined by the study site investigator

    Outcomes

    Primary Outcome Measures

    Change from baseline to Day 30 for Short Form Health Survey, 12-Item SF-12v2 quality of life scores
    Change from baseline to Day 30 for Multidimensional Assessment of Fatigue (MAF) scores
    Change from baseline to Day 30 for Work Productivity and Activity Impairment Questionnaire (WPAI) scores
    Treatment Satisfaction Questionnaire for Medication (TSQM) scores on Day 30

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2013
    Last Updated
    September 7, 2017
    Sponsor
    American Regent, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01950247
    Brief Title
    Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting
    Official Title
    A Multi-Center, Randomized, Open Label Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs. Intravenous Iron Standard of Care for the Treatment of Iron Deficiency Anemia (IDA) in an Infusion Center Setting
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 15, 2013 (Actual)
    Primary Completion Date
    October 20, 2016 (Actual)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    American Regent, Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.
    Detailed Description
    The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia (IDA)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Injectafer
    Arm Type
    Experimental
    Arm Description
    2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
    Arm Title
    IV Iron Standard of Care (SOC)
    Arm Type
    Active Comparator
    Arm Description
    At a dose and administration regimen as determined by the study site investigator
    Intervention Type
    Drug
    Intervention Name(s)
    Injectafer
    Other Intervention Name(s)
    Ferric Carboxymaltose (FCM)
    Intervention Description
    2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
    Intervention Type
    Drug
    Intervention Name(s)
    SOC
    Other Intervention Name(s)
    IV Iron Standard of Care
    Primary Outcome Measure Information:
    Title
    Change from baseline to Day 30 for Short Form Health Survey, 12-Item SF-12v2 quality of life scores
    Time Frame
    Day 30
    Title
    Change from baseline to Day 30 for Multidimensional Assessment of Fatigue (MAF) scores
    Time Frame
    Day 30
    Title
    Change from baseline to Day 30 for Work Productivity and Activity Impairment Questionnaire (WPAI) scores
    Time Frame
    Day 30
    Title
    Treatment Satisfaction Questionnaire for Medication (TSQM) scores on Day 30
    Time Frame
    Day 30

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male or female subjects ≥ 18 years of age and able to give informed consent. Iron deficiency is the primary etiology of anemia. If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days. Doses of potential myelosuppressive medications have been stable for at least 30 days. Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing. Exclusion Criteria: Hypersensitivity reaction to any component of Injectafer. Requires dialysis for treatment of chronic kidney disease (CKD). No evidence of iron deficiency. During the 10 day period prior to screening has been treated with intravenous iron. During the 30 day period prior to screening has been treated with a red red blood cell transfusion. Any non-viral infection. Known positive hepatitis with evidence of active disease. Received an investigational drug within 30 days of screening. Alcohol or drug abuse within the past 6 months. Hemochromatosis or other iron storage disorders. Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1. Pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential). Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sumita Chowdhury, MD
    Organizational Affiliation
    American Regent, Inc.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

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