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

American Regent

Status and phase: Completed; Phase 4

Conditions: Iron Deficiency Anemia (IDA)

Treatments: Drug: SOC; Drug: Injectafer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01950247

1VIT13032

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,025 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,025 participants in 2 patient groups

Injectafer

Experimental group

Description:

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.

Treatment:

Drug: Injectafer

IV Iron Standard of Care (SOC)

Active Comparator group

Description:

At a dose and administration regimen as determined by the study site investigator

Treatment:

Drug: SOC