Georgia's Online Cancer Information Center

Find A Clinical Trial

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA) (FIRM)

Status
Active
Cancer Type
Hematologic Malignancies
Trial Phase
Eligibility
18+, Male and Female
Study Type
Treatment
NCD ID
NCT02694978
Protocol IDs
AMAG-FER-IDA-304 (primary)
Study Sponsor
AMAG Pharmaceuticals, Inc.

Summary

A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
To evaluate the safety of 1.020 g of IV ferumoxytol compared to 1.500 g of IV Ferric Carboxymaltose (FCM).
To assess the incidence of moderate to severe hypersensitivity reactions, including anaphylaxis, and of moderate to severe hypotension.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Iron Deficiency Anemia
  • Drug: Ferumoxytol
    Other Name: Feraheme
  • Drug: Ferric carboxymaltose
    Other Name: Injectafer, Ferinject
  • Experimental: Ferumoxytol
    Intravenous infusion of ferumoxytol 510 mg iron diluted in 233 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes
    Intervention: Drug: Ferumoxytol
  • Active Comparator: ferric carboxymaltose (FCM)
    Intravenous infusion of FCM 750 mg iron diluted in 235 mL 0.9% sodium chloride injection, USP (normal saline) (final volume 250 mL) over at least 15 minutes
    Intervention: Drug: Ferric carboxymaltose
Sampson HA, Muñoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. Ann Emerg Med. 2006 Apr;47(4):373-80.

 

Objectives

Primary Outcome Measures:
Assessing the incidence of moderate to severe hypersensitivity reactions including anaphylaxis and of moderate to severe hypotension [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
To assess the incidence of moderate to severe hypersensitivity reactions, including anaphylaxis, and of moderate to severe hypotension with ferumoxytol as compared to FCM. Signs and symptoms potentially representing hypersensitivity will be recorded and adjudicated by a blinded Clinical Events Committee (CEC). Anaphylaxis will be categorized based on the criteria of Sampson et al, 2006. Hypotension is defined as a 30% drop in systolic blood pressure.
 
 
Secondary Outcome Measures:
Assessing the composite safety endpoint of moderate to severe hypersensitivity reactions, serious cardiovascular events and death. [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
To assess the incidence of the composite safety endpoint of moderate to severe hypersensitivity reactions, serious cardiovascular events, and death for ferumoxytol as compared to FCM. Signs and symptoms potentially representing hypersensitivity will be recorded and adjudicated by a blinded Clinical Events Committee (CEC). Anaphylaxis will be categorized based on the criteria of Sampson et al, 2006.
Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.