Clinical trial NCT02694978: A Phase III Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Official title: A Phase III, Randomized, Multicenter, Double-Blind, Safety Study of Ferumoxytol Compared to Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia (IDA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Keywords: iron deficiency anemia
IDA
ferumoxytol
ferric carboxymaltose
FCM
Injectafer
Feraheme
Ferinject
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 2014
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of 1.020 grams (g) of intravenous (IV) ferumoxytol compared to 1.500 g of IV ferric carboxymaltose (FCM).


Eligibility criteria: Key Inclusion Criteria include:

* Participants with IDA and in whom IV iron treatment is indicated and defined as:

  * Participants with documented hemoglobin \<12.0 g per deciliter (dL) for females and \<14.0 g/dL for males within 60 days of dosing And
  * Participants with documented transferrin saturation (TSAT) ≤20% or Ferritin ≤100 nanograms (ng) per mL within 60 days of dosing
* Documented history of unsatisfactory oral iron therapy or in whom oral iron cannot be tolerated, or for whom oral iron is considered medically inappropriate (as per oral iron history questionnaire)
* All participants (male and female) of childbearing potential who are sexually active who agree to routinely use adequate contraception from randomization throughout the duration of the study

Key Exclusion Criteria include:

* Known hypersensitivity reaction to any component of ferumoxytol or FCM
* History of allergy to an IV iron
* History of multiple drug allergies
* Participants with dialysis-dependent chronic kidney disease
* Hemoglobin ≤7.0 g/dL
* Female participants who are pregnant, intend to become pregnant, are breastfeeding, have a positive serum/urine pregnancy test or not willing to use effective contraceptive precautions during the study (including females of childbearing potential who are partners of male participants)

Primary outcomes:
measure: Participants With Treatment-Emergent (TE) Moderate To Severe Hypersensitivity Reactions (Rxns), Including Anaphylaxis, Or Moderate To Severe Hypotension
timeFrame: Day 1 (after first dosing) through Week 5
Secondary outcomes:
measure: Participants With Moderate To Severe Hypersensitivity Reactions, Including Anaphylaxis, Serious Cardiovascular Events, And Death
timeFrame: Day 1 (after first dosing) through Week 5
measure: Mean Change In Hemoglobin From Baseline To Week 5
timeFrame: Baseline (Day 1), Week 5
measure: Mean Change In Hemoglobin Per Gram Of Iron Administered From Baseline To Week 5
timeFrame: Baseline (Day 1), Week 5
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Clinical Trial Site
state: Alabama
city: Tucson
country: United States
facility: Clinical Trial Site
state: Arizona
city: Tucson
country: United States
facility: Clinical Trial Site
state: Arizona
city: Anaheim
country: United States
facility: Clinical Trial Site
state: California
city: Chula Vista
country: United States
facility: Clinical Trial Site
state: California
city: Corona
country: United States
facility: Clinical Trial Site
state: California
city: Encino
country: United States
facility: Clinical Trial Site
state: California
city: Fountain Valley
country: United States
facility: Clinical Trial Site
state: California
city: Granada Hills
country: United States
facility: Clinical Trial Site
state: California
city: La Mesa
country: United States
facility: Clinical Trial Site
state: California
city: Orange
country: United States
facility: Clinical Trial Site
state: California
city: Oxnard
country: United States
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state: California
city: Riverside
country: United States
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state: California
city: San Diego
country: United States
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state: California
city: West Hollywood
country: United States
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state: California
city: Westminster
country: United States
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state: California
city: Bristol
country: United States
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state: Connecticut
city: Norwalk
country: United States
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state: Connecticut
city: Clearwater
country: United States
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state: Florida
city: Gainesville
country: United States
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state: Florida
city: Lauderdale Lakes
country: United States
facility: Clinical Trial Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Clinical Trial Site
state: Florida
city: Miami Lakes
country: United States
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state: Florida
city: Miami
country: United States
facility: Clinical Trial Site
state: Florida
city: Miami
country: United States
facility: Clinical Trial Site
state: Florida
city: North Miami
country: United States
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state: Florida
city: South Miami
country: United States
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state: Florida
city: West Palm Beach
country: United States
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state: Florida
city: Winter Haven
country: United States
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state: Florida
city: Atlanta
country: United States
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state: Georgia
city: Augusta
country: United States
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state: Georgia
city: Savannah
country: United States
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state: Georgia
city: Thomasville
country: United States
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state: Georgia
city: Elk Grove Village
country: United States
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state: Illinois
city: Evergreen Park
country: United States
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state: Illinois
city: Hazel Crest
country: United States
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state: Illinois
city: Skokie
country: United States
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state: Illinois
city: Skokie
country: United States
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state: Illinois
city: Wichita
country: United States
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state: Kansas
city: Crestview Hills
country: United States
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state: Kentucky
city: Metairie
country: United States
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state: Louisiana
city: New Orleans
country: United States
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state: Louisiana
city: Baltimore
country: United States
facility: Clinical Trial Site
state: Maryland
city: Bethesda
country: United States
facility: Clinical Trial Site
state: Maryland
city: Waltham
country: United States
facility: AMAG Pharmaceuticals, Inc.
state: Massachusetts
city: Bay City
country: United States
facility: Clinical Trial Site
state: Michigan
city: Flint
country: United States
facility: Clinical Trial Site
state: Michigan
city: Saginaw
country: United States
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state: Michigan
city: Saginaw
country: United States
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state: Michigan
city: Chesterfield
country: United States
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state: Missouri
city: Kansas City
country: United States
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state: Missouri
city: Kirksville
country: United States
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state: Missouri
city: Las Vegas
country: United States
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state: Nevada
city: East Setauket
country: United States
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state: New York
city: Flushing
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Rosedale
country: United States
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state: New York
city: Asheville
country: United States
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state: North Carolina
city: Asheville
country: United States
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state: North Carolina
city: Charlotte
country: United States
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state: North Carolina
city: Greensboro
country: United States
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state: North Carolina
city: Hickory
country: United States
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state: North Carolina
city: Jacksonville
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Wilmington
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Winston-Salem
country: United States
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state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Trial Site
state: Ohio
city: Cincinnati
country: United States
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state: Ohio
city: Marion
country: United States
facility: Clinical Trial Site
state: Ohio
city: Norman
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Tulsa
country: United States
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state: Oklahoma
city: Jenkintown
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Levittown
country: United States
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state: Pennsylvania
city: Scottdale
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Upland
country: United States
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state: Pennsylvania
city: Greenville
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Greenville
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Greer
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Rapid City
country: United States
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state: South Dakota
city: Germantown
country: United States
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state: Tennessee
city: Kingsport
country: United States
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state: Tennessee
city: Memphis
country: United States
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state: Tennessee
city: Austin
country: United States
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state: Texas
city: Fort Sam Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Houston
country: United States
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state: Texas
city: Longview
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
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state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
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state: Texas
city: Schertz
country: United States
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state: Texas
city: Orem
country: United States
facility: Clinical Trial Site
state: Utah
city: Fredericksburg
country: United States
facility: Clinical Trial Site
state: Virginia
city: Norfolk
country: United States
facility: Clinical Trial Site
state: Virginia
city: Seattle
country: United States
facility: Clinical Trial Site
state: Washington
city: Sault Ste. Marie
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Vaughan
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Montréal
country: Canada
facility: Clinical Trial Site
state: Quebec
city: Budapest
country: Hungary
facility: Clinical Trial Site
city: Debrecen
country: Hungary
facility: Clinical Trial Site
city: Komárom
country: Hungary
facility: Clinical Trial Site
city: Szekszárd
country: Hungary
facility: Clinical Trial Site
city: Vác
country: Hungary
facility: Clinical Trial Site
city: Jelgava
country: Latvia
facility: Clinical Trial Site
city: Kraslava
country: Latvia
facility: Clinical Trial Site
city: Liepāja
country: Latvia
facility: Clinical Trial Site
city: Riga
country: Latvia
facility: Clinical Trial Site
city: Riga
country: Latvia
facility: Clinical Trial Site
city: Riga
country: Latvia
facility: Clinical Trial Site
city: Ventspils
country: Latvia
facility: Clinical Trial Site
city: Kaunas
country: Lithuania
facility: Clinical Trial Site
city: Kaunas
country: Lithuania
facility: Clinical Trial Site
city: Kaunas
country: Lithuania
facility: Clinical Trial Site
city: Klaipėda
country: Lithuania
facility: Clinical Trial Site
city: Utena
country: Lithuania
facility: Clinical Trial Site
city: Vilnius
country: Lithuania
facility: Clinical Trial Site
city: Šiauliai
country: Lithuania
facility: Clinical Trial Site
city: Białystok
country: Poland
facility: Clinical Trial Site
city: Białystok
country: Poland
facility: Clinical Trial Site
city: Warszawa
country: Poland
facility: Clinical Trial Site
city: Wrocław
country: Poland
facility: Clinical Trial Site
city: Ponce
country: Puerto Rico
facility: Clinical Trial Site
Study officials:
References:
citation: Adkinson NF, Strauss WE, Macdougall IC, Bernard KE, Auerbach M, Kaper RF, Chertow GM, Krop JS. Comparative safety of intravenous ferumoxytol versus ferric carboxymaltose in iron deficiency anemia: A randomized trial. Am J Hematol. 2018 May;93(5):683-690. doi: 10.1002/ajh.25060. Epub 2018 Feb 24.
citation: Adkinson NF, Strauss WE, Bernard K, Kaper RF, Macdougall IC, Krop JS. Comparative safety of intravenous Ferumoxytol versus Ferric Carboxymaltose for the Treatment of Iron Deficiency Anemia: rationale and study design of a randomized double-blind study with a focus on acute hypersensitivity reactions. J Blood Med. 2017 Sep 26;8:155-163. doi: 10.2147/JBM.S142236. eCollection 2017.
citation: Wolf M, Chertow GM, Macdougall IC, Kaper R, Krop J, Strauss W. Randomized trial of intravenous iron-induced hypophosphatemia. JCI Insight. 2018 Dec 6;3(23):e124486. doi: 10.1172/jci.insight.124486.