Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and to Compare Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs Intravenous Standard of Care for the Treatment of IDA in an Infusion Center Setting

A Multi-Center, Randomized, Open Label Trial to Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron and Compare the Safety, Effect on Quality of Life, and Resource Utilization of Injectafer vs. Intravenous Iron Standard of Care for the Treatment of Iron Deficiency Anemia (IDA) in an Infusion Center Setting

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy or to IV iron therapy.

Study Overview

• Status: Unknown
• Conditions: Iron Deficiency Anemia (IDA)
• Intervention / Treatment: Drug: Injectafer; Drug: SOC

Detailed Description

The main objective of this study is to compare the safety, effect on quality of life, and resource utilization of Injectafer vs. intravenous (IV) iron standard of care (SOC) for the treatment of iron deficiency anemia (IDA) in an infusion center setting. The study will also assess the ability of baseline serum hepcidin levels to predict if subjects will have a clinically meaningful hemoglobin response to oral iron therapy for 28 days or to IV iron therapy.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• 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:

• Male or female subjects ≥ 18 years of age and able to give informed consent.
• Iron deficiency is the primary etiology of anemia.
• If using erythropoiesis stimulating agent (ESA), the subject must be using a dose consistent with package insert that has been stable for at least 30 days.
• Doses of potential myelosuppressive medications have been stable for at least 30 days.
• Females at risk of pregnancy must agree to use an acceptable form of birth control and have a negative serum or urine pregnancy test on the first day of dosing.

Exclusion Criteria:

• Hypersensitivity reaction to any component of Injectafer.
• Requires dialysis for treatment of chronic kidney disease (CKD).
• No evidence of iron deficiency.
• During the 10 day period prior to screening has been treated with intravenous iron.
• During the 30 day period prior to screening has been treated with a red 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.
• Estimated life expectancy of less than 6 months, or for cancer patients, an ECOG Performance Status greater than 1.
• Pregnant or actively trying to become pregnant (a definitive negative result on a serum or urine pregnancy test performed on the first day of dosing will be required for study enrollment by any women of childbearing potential).
• 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 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
Experimental: Injectafer; 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.	Drug: Injectafer; 2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.; Other Names: Ferric Carboxymaltose (FCM)
Active Comparator: IV Iron Standard of Care (SOC); At a dose and administration regimen as determined by the study site investigator	Drug: SOC; Other Names: IV Iron Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline to Day 30 for Short Form Health Survey, 12-Item SF-12v2 quality of life scores	Day 30
Change from baseline to Day 30 for Multidimensional Assessment of Fatigue (MAF) scores	Day 30
Change from baseline to Day 30 for Work Productivity and Activity Impairment Questionnaire (WPAI) scores	Day 30
Treatment Satisfaction Questionnaire for Medication (TSQM) scores on Day 30	Day 30

Collaborators and Investigators

• Sponsor: American Regent, Inc.
• Investigators: Study Director: Sumita Chowdhury, MD, American Regent, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2013
• Primary Completion (Actual): October 20, 2016
• Study Completion (Anticipated): October 1, 2017

Study Registration Dates

• First Submitted: September 23, 2013
• First Submitted That Met QC Criteria: September 24, 2013
• First Posted (Estimate): September 25, 2013

Study Record Updates

• Last Update Posted (Actual): September 8, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Anemia
• Other Study ID Numbers: 1VIT13032

Plan for Individual participant data (IPD)

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