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

• ClinicalTrials.gov Identifier: NCT02086968
• Recruitment Status: Completed
• First Posted: March 13, 2014
• Results First Posted: September 17, 2020
• Last Update Posted: September 17, 2020
• Sponsor: American Regent, Inc.
• Information provided by (Responsible Party): American Regent, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Iron Deficiency Anemia Secondary to IBD or Gastric Bypass	Drug: Injectafer; Drug: Ferrous Sulfate tablets	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: January 1, 2014
• Actual Primary Completion Date: July 16, 2016
• Actual Study Completion Date: October 2017

Arms and Interventions

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 Name: 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 Name: Oral Iron tablets

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

American Regent, Inc.

Investigators

• Study Director: Mark A Falone, MD; American Regent, Inc.

More Information

• Responsible Party: American Regent, Inc.
• ClinicalTrials.gov Identifier: NCT02086968
• Other Study ID Numbers: 1VIT13035
• First Posted: March 13, 2014
• Results First Posted: September 17, 2020
• Last Update Posted: September 17, 2020
• Last Verified: September 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neoplasm Metastasis; Inflammatory Bowel Diseases; Anemia; Anemia, Iron-Deficiency; Deficiency Diseases; Hematologic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Malnutrition; Nutrition Disorders