Conditions: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 198
Healthy volunteers: no

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.

Arms:
arm 1: 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 2: Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days

Interventions: intervention 1: Injectafer intervention 2: Ferrous Sulfate tablets
Intervention descriptions: intervention 1: 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 2: 325mg (1 tablet) three times a day for 28 days

Protocol document: