Clinical trial NCT01114217: A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Official title: A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron Deficiency Anemia
Keywords: Iron deficiency anemia
Feraheme
Ferumoxytol
IDA
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-03
Enrollment: 634
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia (IDA).


Eligibility criteria: Key Inclusion Criteria include:

1. Participants who completed participation in study AMAG-FER-IDA-301 \[NCT01114139\]
2. Female participants of childbearing potential who are sexually active must be on an effective method of birth control and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. Experienced a serious adverse event (SAE) related to ferumoxytol in study AMAG-FER-IDA-301
2. Female participants who are pregnant, intend to become pregnant, are breastfeeding, or have a positive serum/urine pregnancy test

Primary outcomes:
measure: Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
timeFrame: TP Baseline (Day 1), TP Week 5
Secondary outcomes:
measure: Mean Change In Hemoglobin Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol After The First Course
timeFrame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
measure: Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5
timeFrame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
measure: Percentage Of Participants Who Achieved A Hemoglobin Level ≥12.0 g/dL At Any Time From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
timeFrame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
measure: Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
timeFrame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
measure: Patient-reported Outcome Measure: Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Questionnaire From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol
timeFrame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
measure: Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
timeFrame: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Clinical Trial Site
state: Alabama
city: Mobile
country: United States
facility: Clinical Trial Site
state: Alabama
city: Montgomery
country: United States
facility: Clinical Trial Site
state: Alabama
city: Montgomery
country: United States
facility: Clinical Trial Site
state: Alabama
city: Phoenix
country: United States
facility: Clinical Trial Site
state: Arizona
city: Phoenix
country: United States
facility: Clinical Trial Site
state: Arizona
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: Bakersfield
country: United States
facility: Clinical Trial Site
state: California
city: Buena Park
country: United States
facility: Clinical Trial Site
state: California
city: Colton
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Los Angeles
country: United States
facility: Clinical Trial Site
state: California
city: Mission Hills
country: United States
facility: Clinical Trial Site
state: California
city: Orange
country: United States
facility: Clinical Trial Site
state: California
city: San Diego
country: United States
facility: Clinical Trial Site
state: California
city: San Diego
country: United States
facility: Clinical Trial Site
state: California
city: San Diego
country: United States
facility: Clinical Trial Site
state: California
city: Pueblo
country: United States
facility: Clinical Trial Site
state: Colorado
city: Bristol
country: United States
facility: Clinical Trial Site
state: Connecticut
city: Groton
country: United States
facility: Clinical Trial Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Clinical Trial Site
state: Florida
city: Boynton Beach
country: United States
facility: Clinical Trial Site
state: Florida
city: Clearwater
country: United States
facility: Clinical Trial Site
state: Florida
city: Clearwater
country: United States
facility: Clinical Trial Site
state: Florida
city: Hialeah
country: United States
facility: Clinical Trial Site
state: Florida
city: Holiday
country: United States
facility: Clinical Trial Site
state: Florida
city: Inverness
country: United States
facility: Clinical Trial Site
state: Florida
city: Margate
country: United States
facility: Clinical Trial Site
state: Florida
city: Miami Lakes
country: United States
facility: Clinical Trial Site
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: Miami
country: United States
facility: Clinical Trial Site
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: Naples
country: United States
facility: Clinical Trial Site
state: Florida
city: Vero Beach
country: United States
facility: Clinical Trial Site
state: Florida
city: West Palm Beach
country: United States
facility: Clinical Trial Site
state: Florida
city: Zephyrhills
country: United States
facility: Clinical Trial Site
state: Florida
city: Atlanta
country: United States
facility: Clinical Trial Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Trial Site
state: Georgia
city: Atlanta
country: United States
facility: Clinical Trial Site
state: Georgia
city: Decatur
country: United States
facility: Clinical Trial Site
state: Georgia
city: Dublin
country: United States
facility: Clinical Trial Site
state: Georgia
city: Sandy Springs
country: United States
facility: Clinical Trial Site
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Trial Site
state: Georgia
city: Aurora
country: United States
facility: Clinical Trial Site
state: Illinois
city: Chicago
country: United States
facility: Clinical Trial Site
state: Illinois
city: Skokie
country: United States
facility: Clinical Trial Site
state: Illinois
city: Skokie
country: United States
facility: Clinical Trial Site
state: Illinois
city: Springfield
country: United States
facility: Clinical Trial Site
state: Illinois
city: Wichita
country: United States
facility: Clinical Trial Site
state: Kansas
city: New Orleans
country: United States
facility: Clinical Trial Site
state: Louisiana
city: Bethesda
country: United States
facility: Clinical Trial Site
state: Maryland
city: Hollywood
country: United States
facility: Clinical Trial Site
state: Maryland
city: Bay City
country: United States
facility: Clinical Trial Site
state: Michigan
city: Bay City
country: United States
facility: Clinical Trial Site
state: Michigan
city: Wyoming
country: United States
facility: Clinical Trial Site
state: Michigan
city: Kansas City
country: United States
facility: Clinical Trial Site
state: Missouri
city: Las Vegas
country: United States
facility: Clinical Trial Site
state: Nevada
city: Lawrenceville
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Neptune
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Plainsboro
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Voorhees
country: United States
facility: Clinical Trial Site
state: New Jersey
city: Albuquerque
country: United States
facility: Clinical Trial Site
state: New Mexico
city: Brooklyn
country: United States
facility: Clinical Trial Site
state: New York
city: New York
country: United States
facility: Clinical Trial Site
state: New York
city: Raleigh
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Clinical Trial Site
state: North Carolina
city: Canton
country: United States
facility: Clinical Trial Site
state: Ohio
city: Carlisle
country: United States
facility: Clinical Trial Site
state: Ohio
city: Cincinnati
country: United States
facility: Clinical Trial Site
state: Ohio
city: Cincinnati
country: United States
facility: Clinical Trial Site
state: Ohio
city: Columbus
country: United States
facility: Clinical Trial Site
state: Ohio
city: Marion
country: United States
facility: Clinical Trial Site
state: Ohio
city: Marion
country: United States
facility: Clinical Trial Site
state: Ohio
city: Mentor
country: United States
facility: Clinical Trial Site
state: Ohio
city: Middletown
country: United States
facility: Clinical Trial Site
state: Ohio
city: Zanesville
country: United States
facility: Clinical Trial Site
state: Ohio
city: Norman
country: United States
facility: Clinical Trial Site
state: Oklahoma
city: Jenkintown
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Levittown
country: United States
facility: Clinical Trial Site
state: Pennsylvania
city: Columbia
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Greer
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Clinical Trial Site
state: South Carolina
city: North Charleston
country: United States
facility: Clinical Trial Site
state: South Carolina
city: Rapid City
country: United States
facility: Clinical Trial Site
state: South Dakota
city: Arlington
country: United States
facility: Clinical Trial Site
state: Texas
city: Dallas
country: United States
facility: Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site
state: Texas
city: Houston
country: United States
facility: Clinical Trial Site
state: Texas
city: Laredo
country: United States
facility: Clinical Trial Site
state: Texas
city: Longview
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: San Antonio
country: United States
facility: Clinical Trial Site
state: Texas
city: Orem
country: United States
facility: Clinical Trial Site
state: Utah
city: Chesapeake
country: United States
facility: Clinical Trial Site
state: Virginia
city: Norfolk
country: United States
facility: Clinical Trial Site
state: Virginia
city: Vancouver
country: Canada
facility: Clinical Trial Site
state: British Columbia
city: Saint John
country: Canada
facility: Clinical Trial Site
state: New Brunswick
city: London
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Thornhill
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Vaughan
country: Canada
facility: Clinical Trial Site
state: Ontario
city: Pointe-Claire
country: Canada
facility: Clinical Trial Site
state: Quebec
city: Bekescsaba
country: Hungary
facility: Clinical Trial Site
city: Gyula
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: Hyderabad
country: India
facility: Clinical Trial Site
state: Andhra Pradesh
city: Secunderabad
country: India
facility: Clinical Trial Site
state: Andhra Pradesh
city: Guwahati
country: India
facility: Clinical Trial Site
state: Assam
city: Bangalore
country: India
facility: Clinical Trial Site
state: Karnataka
city: Bangalore
country: India
facility: Clinical Trial Site
state: Karnataka
city: Aurangabad
country: India
facility: Clinical Trial Site
state: Maharashtra
city: Nagpur
country: India
facility: Clinical Trial Site
state: Maharashtra
city: Nashik
country: India
facility: Clinical Trial Site
state: Maharashtra
city: Pune
country: India
facility: Clinical Trial Site
state: Maharashtra
city: Jaipur
country: India
facility: Clinical Trial Site
state: Rajasthan
city: Chennai
country: India
facility: Clinical Trial Site
state: Tamil Nadu
city: Madurai
country: India
facility: Clinical Trial Site
state: Tamil Nadu
city: Lucknow
country: India
facility: Clinical Trial Site
state: Uttar Pradesh
city: Lucknow
country: India
facility: Clinical Trial Site
state: Uttar Pradesh
city: Daugavpils
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: Riga
country: Latvia
facility: Clinical Trial Site
city: Valmiera
country: Latvia
facility: Clinical Trial Site
city: Ventspils
country: Latvia
facility: Clinical Trial Site
city: Ventspils
country: Latvia
facility: Clinical Trial Site
city: Białystok
country: Poland
facility: Clinical Trial Site
city: Sopot
country: Poland
facility: Clinical Trial Site
city: Warszawa
country: Poland
facility: Clinical Trial Site
city: Wrocław
country: Poland
facility: Clinical Trial Site
Study officials:
References:
citation: Vadhan-Raj S, Ford DC, Dahl NV, Bernard K, Li Z, Allen LF, Strauss WE. Safety and efficacy of ferumoxytol for the episodic treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy: Results of a phase III, open-label, 6-month extension study. Am J Hematol. 2016 Feb;91(2):E3-5. doi: 10.1002/ajh.24240. No abstract available.