Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support
Overview
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- NYU Langone Health
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 110 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Ferumoxytol injection treatment
Intervention: Ferumoxytol injection (Drug)
Outcomes
Primary Outcomes
Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
Time Frame: Month 6
Secondary Outcomes
No secondary outcomes reported