Trial Outcomes & Findings for Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support (NCT NCT04080908)

Last Updated: 2023-07-18

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

1 participants

Primary outcome timeframe

Month 6

Results posted on

2023-07-18

Participant milestones
Measure	Ferumoxytol Injection Treatment Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Ferumoxytol Injection Treatment n=1 Participants Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Age, Continuous	41 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

Timeframe: Month 6

Outcome measures
Measure	Ferumoxytol Injection Treatment n=1 Participants Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment	100 percentage of participants Standard Deviation 0

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Ferumoxytol Injection Treatment n=1 participants at risk Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Surgical and medical procedures Hospitalization - planned heart transplant, ICD and VAD removal	100.0% 1/1 • 6 months Non-Systematic - subject reported and chart review
Injury, poisoning and procedural complications Pneumoperitoneum	100.0% 1/1 • 6 months Non-Systematic - subject reported and chart review
Endocrine disorders Steriod Induced Hyperglycemia	100.0% 1/1 • 6 months Non-Systematic - subject reported and chart review
Musculoskeletal and connective tissue disorders left shoulder disorder	100.0% 1/1 • 6 months Non-Systematic - subject reported and chart review

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