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

Phase 4

Terminated

• Conditions: Anemia
• Interventions: Drug: Ferumoxytol injection

• Registration Number: NCT04080908
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-04
• Study First Posted: 2019-09-06
• Study Start: 2020-01-15
• Primary Completion: 2021-10-19
• Study Completion: 2021-10-19
• Status Verified: 2023-06
• Results First Submitted: 2023-06-29
• Results First Submitted QC: 2023-06-29
• Last Update Submitted: 2023-06-29
• Results First Posted: 2023-07-18
• Last Update Posted: 2023-07-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ferumoxytol injection treatment	Ferumoxytol injection	-

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment	Month 6

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States