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

NCT04080908 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 19-00866
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Successfully Complete Ferumoxytol Injection Treatment

  Month 6

Study Arms (1)

Ferumoxytol injection treatment

EXPERIMENTAL

Drug: Ferumoxytol injection

Interventions

Ferumoxytol injection DRUG

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

Ferumoxytol injection treatment

Eligibility Criteria

• Age: 19 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Results Point of Contact

• Title: Stuart Katz
• Organization: NYU Langone Health

Stuart.Katz@nyulangone.org

2122633946

Study Officials

• Stuart Katz, MD

  New York Langone Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 6, 2019
• Study Start: January 15, 2020
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: July 18, 2023
• Results First Posted: July 18, 2023

Record last verified: 2023-06

Locations

US (1)