Evaluate the Utility of Serum Hepcidin Levels to Predict Response to Oral or IV Iron

Phase 4CompletedNCT01950247

American Regent, Inc.1,025 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,025

Conditions

Iron Deficiency Anemia (IDA)

Interventions

InjectaferDRUG

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.

SOCDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 Eastern Cooperative Oncology Group (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.

Outcomes

Primary Outcomes

Multidimensional Assessment of Fatigue (MAF) Scores

The MAF scale has 16 items that measure the Global Fatigue Index (GFI), a composite score of Items 1 through 15. Items 1 through 14 were measured on a scale of 1 to 10, with 1 = not at all and 10 = a great deal. Items 15 and 16 had categorical responses: degree of agreement from 0 to 4, with 0=no days and 4=every day. Then, a Global Fatigue Index (GFI) is calculated by summing specific items and averaging others. The final GFI score ranges from 1 (no fatigue) to 50 (severe fatigue). The resulting score is given as the mean value.

Time frame: Baseline to Day 30

Work Productivity and Activity Impairment Questionnaire (WPAI) Scores

The WPAI consisted of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working using a scale of 0 to 10, with 0 = PROBLEM had no effect on my work and 10 = PROBLEM completely prevented me from working; 6 = degree health affected productivity in regular unpaid activities using a scale of 0 to 10, with 0 = PROBLEM had no effect on my daily activities and 10 = PROBLEM completely prevented me from doing my daily activities. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity.

Time frame: Baseline and Day 30

Treatment Satisfaction Questionnaire for Medication Version 1.4 Scores

Participants rated 14 items with 4 domains. Scores for item 1 to 3, 9 to 11 and 14 ranged from 1=extremely dissatisfied to 7=extremely satisfied. Items 5 to 8, 12, 13 ranged from 1=extremely dissatisfied to 5=not at all dissatisfied. Item 4 was scored as: 0=No, 1=Yes. Effectiveness measured as (\[{sum of item 1 to 3} - 3\]/18)\*100; if 1 question (Q) was missing: (\[{sum of item 1 to 3} -2\]/12)\*100. Side-effect measured as if item 4=No, score=100; if not then (\[{sum of item 5 to 8} -4\]/16)\*100; if 1 Q was missing: (\[{sum of item 5 to 8} -3\]/12)\*100. Convenience measured as (\[{sum of item 9 to 11} -3\]/18)\*100; if 1 Q was missing: (\[{sum of item 9 to 11} - 2\]/12)\*100. Global satisfaction as (\[{sum of item 12 to 14} -3\]/14)\*100; if item 12 or 13 was missing: (\[{sum of item 12 to 14} -2\]/10)\*100; if item 14 was missing: (\[{sum of item 12 and 13} -2\]/8)\*100. All domains had scale of 0 (no satisfaction) to 100 (best level of satisfaction), higher score equals greater satisfaction

Data from ClinicalTrials.gov

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