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

NCT ID: NCT04080908

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2021-10-19

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.

Conditions

Anemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferumoxytol injection treatment

Group Type: EXPERIMENTAL

Ferumoxytol injection

Intervention Type: DRUG

Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.

Interventions

Ferumoxytol injection

Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stuart Katz, MD

Role: PRINCIPAL_INVESTIGATOR

New York Langone Medical Center

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19-00866

Identifier Type: -

Identifier Source: org_study_id