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

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.

Study Overview

• Status: Completed
• Conditions: Iron Deficiency Anemia Secondary to IBD or Gastric Bypass
• Intervention / Treatment: Drug: Injectafer; Drug: Ferrous Sulfate tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 198
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: Ferric Carboxymaltose (FCM)
Active Comparator: Ferrous Sulfate tablets; Oral Ferrous Sulfate at 325 mg (1 tablet) three times a day for 28 days	Drug: Ferrous Sulfate tablets; 325mg (1 tablet) three times a day for 28 days; Other Names: Oral Iron tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Between Screening Hepcidin and Change in Hemoglobin From Baseline to Highest Observed Hemoglobin Change (Proportion of Responders).	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.	anytime between baseline and end of study (day 28) or time of intervention

Collaborators and Investigators

• Sponsor: American Regent, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): July 16, 2016
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: March 12, 2014
• First Submitted That Met QC Criteria: March 12, 2014
• First Posted (Estimate): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 16, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Neoplasms; Hematologic Diseases; Gastrointestinal Diseases; Nutrition Disorders; Gastroenteritis; Intestinal Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Neoplastic Processes; Malnutrition; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Neoplasm Metastasis; Anemia; Deficiency Diseases
• Other Study ID Numbers: 1VIT13035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No