Neoplasms

Symptoms and General Pathology

All Conditions

Blood and Lymph Conditions

Nutritional and Metabolic Diseases

Digestive System Diseases

Neoplasm Metastasis

Anemia

Anemia, Iron-Deficiency

Iron Deficiencies

Inflammatory Bowel Diseases

Intestinal Diseases

Deficiency Diseases

Hematologic Diseases

Neoplastic Processes

Gastrointestinal Diseases

Gastroenteritis

Metabolic Diseases

Iron Metabolism Disorders

Anemia, Hypochromic

Malnutrition

Nutrition Disorders

Micronutrients

All Drugs and Chemicals

Anti-Infective Agents

Mineral

Iron

Hepcidins

Iron Supplement

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

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

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

Injectafer

325mg (1 tablet) three times a day for 28 days

Ferrous Sulfate tablets

Mark A Falone, MD

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.

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.

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

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.

American Regent, Inc.

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

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

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

Ferrous Sulfate tablets: 325mg (1 tablet) three times a day for 28 days

Ferrous Sulfate Tablets

Total

Age, Continuous

Sex: Female, Male

White

Black/African American

Asian

American Indian/Alaska Native

The category of Race is Check All That Apply. In the Injectafer group, two subjects didn't check any options and one subject checked two options. In the Oral Iron group, one subject checked two options.

Race/Ethnicity, Customized

United States

Region of Enrollment

Included subjects who received at least 1 dose of randomized treatment and had at least 1 post-randomization measurement of hemoglobin

Point of Care Hemoglobin

Of the 198 subjects randomized, two subjects (one in each group) were not treated.

The study was stopped early due to slow enrollment, however it was not considered prematurely terminated. A total of 198 of the 400 subjects planned were randomized, 196 were treated, and the study concluded normally.

Spots Global Cancer Trial Database for iron deficiency anemia secondary to ibd or gastric bypass