Anemia
Conditions
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.
Interventions
Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 110 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment | Month 6 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ferumoxytol Injection Treatment Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart. | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Ferumoxytol Injection Treatment |
|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 0 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1 |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment
Time frame: Month 6
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ferumoxytol Injection Treatment | Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment | 100 percentage of participants | Standard Deviation 0 |