NCT04080908: AMAGFeraheme

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

Terminated Phase 4 Results posted Last updated 18 July 2023

What this trial tests

Phase 4 trial testing Ferumoxytol injection in Anemia in 1 participant. Terminated before completion.

Timeline

15 January 2020

Primary endpoint
19 October 2021

19 October 2021

Quick facts

Lead sponsor	NYU Langone Health
Phase	Phase 4
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	15 January 2020
Primary completion	19 October 2021
Estimated completion	19 October 2021
Sites	1 location across United States

Drugs / interventions tested

• Ferumoxytol injection — full drug profile →

Conditions studied

• Anemia — all drugs for Anemia →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 19 to 110, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment Primary · Month 6

Group	Value	95% CI
Ferumoxytol Injection Treatment	100	± 0

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Ferumoxytol Injection Treatment

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (4 terms — click to expand)

Reaction	System	Ferumoxytol Injection Trea…
Hospitalization - planned heart transplant, ICD and VAD removal	Surgical and medical procedures	—
Pneumoperitoneum	Injury, poisoning and procedural complications	—
Steriod Induced Hyperglycemia	Endocrine disorders	—
left shoulder disorder	Musculoskeletal and connective tissue disorders	—

Data from ClinicalTrials.gov NCT04080908 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. New Opportunities and Old Challenges in the Clinical translation of Nanotheranostics.
   Gawne PJ, Ferreira M, Papaluca M, Grimm J, et al · · 2023 · cited 112× · PMID 39022623 · DOI 10.1038/s41578-023-00581-x