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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Intervention / Treatment
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* Drug: Injectafer
* Drug: Ferrous Sulfate tablets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Injectafer<br>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 | Drug: Injectafer<br>* 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<br>* Other names: Ferric Carboxymaltose (FCM);|
| Active Comparator: Ferrous Sulfate tablets<br>Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days | Drug: Ferrous Sulfate tablets<br>* 325mg (1 tablet) three times a day for 28 days<br>* Other names: Oral Iron tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | anytime between baseline and end of study (day 28) or time of intervention |