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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

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ClinicalTrials.gov Identifier: NCT02086968
Recruitment Status : Completed
First Posted : March 13, 2014
Results First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Tracking Information
First Submitted Date  ICMJE March 12, 2014
First Posted Date  ICMJE March 13, 2014
Results First Submitted Date  ICMJE December 11, 2017
Results First Posted Date  ICMJE September 17, 2020
Last Update Posted Date September 17, 2020
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date July 16, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2020)
Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders). [ Time Frame: anytime between baseline and end of study (day 28) or time of intervention ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 12, 2014)
Correlation between screening hepcidin and change in hemoglobin from baseline to highest observed hemoglobin change. [ Time Frame: anytime between baseline and end of study (day 28) or time of intervention ]
The primary endpoint is the correlation between screening hepcidin and change in hemoglobin from baseline to highest observed hemoglobin change.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Intervention  ICMJE
  • Drug: Injectafer
    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
    Other Name: Ferric Carboxymaltose (FCM)
  • Drug: Ferrous Sulfate tablets
    325mg (1 tablet) three times a day for 28 days
    Other Name: Oral Iron tablets
Study Arms  ICMJE
  • Active Comparator: Injectafer
    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
    Intervention: Drug: Injectafer
  • Active Comparator: Ferrous Sulfate tablets
    Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
    Intervention: Drug: Ferrous Sulfate tablets
Publications * Not Provided

*   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: September 16, 2020)
198
Original Estimated Enrollment  ICMJE
 (submitted: March 12, 2014)
400
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date July 16, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02086968
Other Study ID Numbers  ICMJE 1VIT13035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party American Regent, Inc.
Study Sponsor  ICMJE American Regent, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark A Falone, MD American Regent, Inc.
PRS Account American Regent, Inc.
Verification Date September 2020

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