NCT04080908

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

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 19 Years – 110 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	Ferumoxytol injection	Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.

Timeline

• Start date: 2020-01-15
• Primary completion: 2021-10-19
• Completion: 2021-10-19
• First posted: 2019-09-06
• Last updated: 2023-07-18
• Results posted: 2023-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study