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

American Regent

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Treatments: Drug: Ferrous Sulfate tablets; Drug: Injectafer

Study type: Interventional

Funder types: Industry

Identifiers

NCT02086968

1VIT13035

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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198 participants in 2 patient groups

Injectafer

Active Comparator group

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

Treatment:

Drug: Injectafer

Ferrous Sulfate tablets

Active Comparator group

Description:

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

Treatment:

Drug: Ferrous Sulfate tablets