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

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Ferrous Sulfate tablets	Ferrous Sulfate tablets	Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days
Injectafer	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

Primary Outcome Measures

Name	Time	Method
Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).	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.

Secondary Outcome Measures