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

Anemia Clinical Trial

— AMAGFeraheme  

Official title:

Open Label Single Arm Pilot Study to Assess Feasibility and Safety of Iron Repletion With Feraheme in Iron Deficient Patients With Durable Ventricular Assist Device Support

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04080908
• Other study ID #: 19-00866
• Status: Terminated
• Phase: Phase 4
• Start date: January 15, 2020
• Est. completion date: October 19, 2021

Study information

• Verified date: June 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 19, 2021
• Est. primary completion date: October 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• Ferumoxytol injection
Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment		Month 6