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Unable to meet enrollment goals.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferumoxytol injection treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferumoxytol injection | Drug | Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Katz, MD | New York Langone Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferumoxytol Injection Treatment | Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferumoxytol Injection Treatment | Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment | Posted | Mean | Standard Deviation | percentage of participants | Month 6 |
|
|
6 months
Non-Systematic - subject reported and chart review
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferumoxytol Injection Treatment | Ferumoxytol injection: Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization - planned heart transplant, ICD and VAD removal | Surgical and medical procedures | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Katz | NYU Langone Health | 2122633946 | Stuart.Katz@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 15, 2022 | Jun 29, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D052203 | Ferrosoferric Oxide |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005296 | Ferrous Compounds |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| Pneumoperitoneum | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Steriod Induced Hyperglycemia | Endocrine disorders | Non-systematic Assessment |
|
| left shoulder disorder | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D008903 |
| Minerals |