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Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

Primary Purpose

Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Injectafer
Ferrous Sulfate tablets
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 Secondary to IBD or Gastric Bypass

Eligibility Criteria

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

Inclusion Criteria:

  • Signed informed consent
  • Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to IBD or Gastric Bypass
  • Screening Hemoglobin (Hb) ≤ 11g/dL
  • Screening Ferritin ≤ 100 ng/mL
  • Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study

Exclusion Criteria:

  • Hypersensitivity reaction to any component of IV Injectafer or oral iron
  • Requires dialysis for treatment of chronic kidney disease (CKD)
  • During the 30 day period prior to screening has been treated with IV iron
  • No evidence of iron deficiency
  • During the 30 day period prior to screening has been treated with a 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
  • Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary
  • Alcohol or drug abuse within the past 6 months
  • Hemochromatosis or other iron storage disorders
  • Pregnant
  • 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 the study requirements

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Injectafer

    Ferrous Sulfate tablets

    Arm Description

    2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg

    Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

    Outcomes

    Primary Outcome Measures

    Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).
    Responders were defined as subjects achieving an increase from baseline ≥2 g/dL at anytime between baseline and the end of the study (Day 28). The relation between screening hepcidin and change in hemoglobin was assessed with regression models with baseline hepcidin and treatment group as independent factors. Treatment group differences (oral vs. IV iron) for mean changes in endpoints were assessed with the analysis of covariance with a fixed factor for treatment and baseline value as covariate. Treatment group differences for proportions were assessed with the normal approximation to the binomial distribution.

    Secondary Outcome Measures

    Full Information

    First Posted
    March 12, 2014
    Last Updated
    September 16, 2020
    Sponsor
    American Regent, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02086968
    Brief Title
    Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
    Official Title
    Multicenter Randomized Open-label Controlled Study to Investigate Treatment Response of IV Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia Secondary to Inflammatory Bowel Disease or Gastric Bypass
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    July 16, 2016 (Actual)
    Study Completion Date
    October 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron to baseline hepcidin levels to determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.
    Detailed Description
    The primary objective of this study is to evaluate the treatment response of Injectafer vs. oral iron in patients with varying hepcidin levels correlating the treatment response/hepcidin levels to more common laboratory parameters such as ferritin and CRP (C-Reactive Protein) levels and possibly determine if any of these select IBD or Gastric Bypass patients may demonstrate to be inappropriate for oral iron therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Injectafer
    Arm Type
    Active Comparator
    Arm Description
    2 doses of Injectafer, at 15 mg/kg for a maximum single dose of 750 mg given on Days 0 and 7 for a total of up to 1500 mg
    Arm Title
    Ferrous Sulfate tablets
    Arm Type
    Active Comparator
    Arm Description
    Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
    Intervention Type
    Drug
    Intervention Name(s)
    Injectafer
    Other Intervention Name(s)
    Ferric Carboxymaltose (FCM)
    Intervention Description
    2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg
    Intervention Type
    Drug
    Intervention Name(s)
    Ferrous Sulfate tablets
    Other Intervention Name(s)
    Oral Iron tablets
    Intervention Description
    325mg (1 tablet) three times a day for 28 days
    Primary Outcome Measure Information:
    Title
    Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).
    Description
    Responders were defined as subjects achieving an increase from baseline ≥2 g/dL at anytime between baseline and the end of the study (Day 28). The relation between screening hepcidin and change in hemoglobin was assessed with regression models with baseline hepcidin and treatment group as independent factors. Treatment group differences (oral vs. IV iron) for mean changes in endpoints were assessed with the analysis of covariance with a fixed factor for treatment and baseline value as covariate. Treatment group differences for proportions were assessed with the normal approximation to the binomial distribution.
    Time Frame
    anytime between baseline and end of study (day 28) or time of intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Male or female subjects ≥ 18 years of age with clinical diagnosis of IDA secondary to IBD or Gastric Bypass Screening Hemoglobin (Hb) ≤ 11g/dL Screening Ferritin ≤ 100 ng/mL Female subjects who are of childbearing age must have a negative pregnancy test at screening and be practicing an acceptable method of birth control during the study Exclusion Criteria: Hypersensitivity reaction to any component of IV Injectafer or oral iron Requires dialysis for treatment of chronic kidney disease (CKD) During the 30 day period prior to screening has been treated with IV iron No evidence of iron deficiency During the 30 day period prior to screening has been treated with a 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 Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary Alcohol or drug abuse within the past 6 months Hemochromatosis or other iron storage disorders Pregnant 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 the study requirements
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mark A Falone, 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

    Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass

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