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

NCT04080908 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2023-07-18

Study results available
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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

Interventions

DRUG

Ferumoxytol injection

Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.

Sponsors & Collaborators

Principal Investigators

  • Stuart Katz, MD · New York Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-15
Primary Completion
2021-10-19
Completion
2021-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04080908 on ClinicalTrials.gov