NCT02086968

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Interventions

Type	Name	Description
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
DRUG	Ferrous Sulfate tablets	325mg (1 tablet) three times a day for 28 days

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-07-16
• Completion: 2017-10-01
• First posted: 2014-03-13
• Last updated: 2020-09-17
• Results posted: 2020-09-17

Regulatory

• FDA-regulated drug study