Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support (AMAGFeraheme)

NYU Langone Health

Status and phase: Terminated; Phase 4

Conditions: Anemia

Treatments: Drug: Ferumoxytol injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04080908

19-00866

Details and patient eligibility

About

Ferumoxytol injection (Feraheme®) is a parenteral form of iron supplementation that is FDA-approved for treatment of iron deficiency anemia. Ferumoxytol injection achieves iron repletion in fewer doses (2) when compared with other available injectable iron formulations (5-6) available at NYU Langone Health, and thus may be useful to reduce travel burden and expedite full iron repletion in patients with iron deficiency. Iron-deficiency anemia is common in patients after placement of a ventricular assist device (VAD) for treatment of end-stage heart disease. This is a pilot study to test the feasibility of iron repletion with ferumoxytol injection in 20 eligible subjects with laboratory evidence of iron deficiency after placement of a VAD.

Enrollment: 1 patient

Sex: All

Ages: 19 to 110 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Status post placement of durable ventricular assist device with stable clinical status for >30days
• Hemoglobin >6 g/dL AND <13 g/dL (men) or <12 g/dL (women) within last 90 days
• Serum ferritin <100 ng/mL OR Serum ferritin 100-299 ng/mL with transferrin saturation <20% within last 90 days
• Able and willing to provide written informed consent

Exclusion criteria

• Known hypersensitivity to Ferumoxytol injection or other intravenous iron preparation
• History of anaphylaxis
• Treatment with erythropoiesis stimulating agent or intravenous iron in last 3 months
• Renal failure on hemodialysis
• Respiratory failure on mechanical ventilation
• Disabling Stroke
• Ventricular assist device thrombosis
• Evidence of active gastrointestinal bleeding or other active blood loss
• Hospitalization <30 days
• Pregnant or breastfeeding women

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Ferumoxytol injection treatment

Experimental group

Treatment:

Drug: Ferumoxytol injection