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

NCT02086968 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 1VIT13035
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Iron Deficiency Anemia Secondary to IBD or Gastric Bypass

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Injectafer

ACTIVE COMPARATOR

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

Ferrous Sulfate tablets

ACTIVE COMPARATOR

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

Drug: Ferrous Sulfate tablets

Interventions

Injectafer DRUG

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

Also known as: Ferric Carboxymaltose (FCM)

Injectafer

Ferrous Sulfate tablets DRUG

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

Also known as: Oral Iron tablets

Ferrous Sulfate tablets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• American Regent, Inc.: lead

MeSH Terms

Interventions

ferric carboxymaltose; Iron-Dextran Complex; Iron

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Dextrans; Glucans; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Limitations and Caveats

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.

Results Point of Contact

• Title: Angelia Butcher
• Organization: Luitpold Pharmaceuticals, Inc.

abutcher@lpicrd.com

610-650-4200

Study Officials

• Mark A Falone, MD

  American Regent, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 13, 2014
• Study Start: January 1, 2014
• Primary Completion: July 16, 2016
• Study Completion: October 1, 2017
• Last Updated: September 17, 2020
• Results First Posted: September 17, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share