A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

NCT01114217 | Completed Phase 3 Results DMC

• 1 other identifier: AMAG-FER-IDA-303
• Study Type: interventional
• Target: 634
• Locations: 6 countries
• Sites: 140

Brief Summary

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

Conditions

Iron Deficiency Anemia

Keywords

Iron deficiency anemia; Feraheme; Ferumoxytol; IDA

Outcome Measures

Primary Outcomes (1)

• Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol

  Mean change in hemoglobin from TP Baseline (Day 1) to TP Week 5 following the first dose of ferumoxytol was calculated as: Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing of Course 1. Change from Baseline used an imputed value of 0 for missing values at the post-baseline visit.

  TP Baseline (Day 1), TP Week 5

Secondary Outcomes (6)

• 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

  TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

• Percentage Of Participants With An Increase In Hemoglobin ≥2.0 g/dL At Any Time From TP Baseline To TP Week 5

  TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

• 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

  TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

• Mean Change In TSAT Following Each Course Of Ferumoxytol From TP Baseline To TP Week 5 Following Each Course Of Ferumoxytol

  TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

• 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

  TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

Study Arms (1)

Ferumoxytol

EXPERIMENTAL

Participants received ferumoxytol or placebo during AMAG-FER-IDA-301 \[NCT01114139\]. Participants enrolled in AMAG-FER-IDA-303, a 6-month Extension Study, were evaluated monthly and could receive treatment with ferumoxytol only if they met criteria defined as persistent or recurrent IDA, hemoglobin \<11.0 grams per deciliter (g/dL) and transferrin saturation (TSAT) \<20% at any evaluation visit, (except study termination visit). Participants who met criteria began a 5-week treatment period (TP) and received 2 doses of ferumoxytol 510 mg intravenously (IV). The first IV 510-mg dose was administered on TP Day 1 (Baseline); the second 2-8 (5±3) days after Dose 1. The first treatment course with ferumoxytol for participants who previously received placebo in AMAG-FER-IDA-301 was considered Course 1; Course 2 included participants who previously received ferumoxytol in AMAG-FER-IDA-301; subsequent treatment courses were serially numbered.

Drug: Ferumoxytol

Interventions

Ferumoxytol DRUG

IV Ferumoxytol

Also known as: Feraheme

Ferumoxytol

Eligibility Criteria

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

You may qualify if:

• Participants who completed participation in study AMAG-FER-IDA-301 \[NCT01114139\]
• 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

You may not qualify if:

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

Sponsors & Collaborators

• AMAG Pharmaceuticals, Inc.: lead

Study Sites (140)

Clinical Trial Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Montgomery, Alabama, 36106, United States

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Montgomery, Alabama, 36116, United States

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Phoenix, Arizona, 85015, United States

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Phoenix, Arizona, 85032, United States

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Tucson, Arizona, 85710, United States

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Tucson, Arizona, 85712, United States

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Anaheim, California, United States

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Bakersfield, California, United States

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Buena Park, California, United States

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Colton, California, United States

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Los Angeles, California, 90036, United States

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Los Angeles, California, 90057, United States

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Los Angeles, California, United States

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Mission Hills, California, United States

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Orange, California, United States

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San Diego, California, 92103, United States

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San Diego, California, 92121, United States

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San Diego, California, 92123, United States

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Pueblo, Colorado, United States

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Bristol, Connecticut, United States

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Groton, Connecticut, United States

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Boynton Beach, Florida, 33426, United States

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Boynton Beach, Florida, 33472, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33759, United States

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Hialeah, Florida, United States

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Holiday, Florida, United States

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Inverness, Florida, United States

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Margate, Florida, United States

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Miami, Florida, 33126, United States

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Miami, Florida, 33135, United States

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Miami, Florida, 33143, United States

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Miami, Florida, 33144, United States

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Miami, Florida, 33175, United States

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Miami Lakes, Florida, United States

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Naples, Florida, United States

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Vero Beach, Florida, United States

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West Palm Beach, Florida, United States

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Zephyrhills, Florida, United States

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Atlanta, Georgia, 30308, United States

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Atlanta, Georgia, 30312, United States

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Atlanta, Georgia, 30342, United States

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Decatur, Georgia, United States

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Dublin, Georgia, United States

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Sandy Springs, Georgia, United States

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Stockbridge, Georgia, United States

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Aurora, Illinois, United States

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Chicago, Illinois, 60616, United States

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Skokie, Illinois, 60076, United States

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Skokie, Illinois, United States

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Springfield, Illinois, United States

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Wichita, Kansas, United States

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New Orleans, Louisiana, United States

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Bethesda, Maryland, United States

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Hollywood, Maryland, United States

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Bay City, Michigan, 48706, United States

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Bay City, Michigan, United States

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Wyoming, Michigan, United States

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Kansas City, Missouri, United States

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Las Vegas, Nevada, United States

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Lawrenceville, New Jersey, United States

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Neptune City, New Jersey, United States

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Plainsboro, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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New York, New York, 10038, United States

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Raleigh, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Canton, Ohio, United States

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Carlisle, Ohio, United States

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Cincinnati, Ohio, 45224, United States

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Cincinnati, Ohio, 45242, United States

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Columbus, Ohio, 43231, United States

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Marion, Ohio, 43302, United States

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Marion, Ohio, United States

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Mentor, Ohio, United States

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Middletown, Ohio, United States

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Zanesville, Ohio, United States

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Norman, Oklahoma, United States

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Jenkintown, Pennsylvania, United States

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Levittown, Pennsylvania, United States

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Columbia, South Carolina, United States

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Greer, South Carolina, United States

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Myrtle Beach, South Carolina, United States

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North Charleston, South Carolina, United States

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Rapid City, South Dakota, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, 77030, United States

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Houston, Texas, 77074, United States

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Houston, Texas, United States

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Laredo, Texas, United States

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Longview, Texas, United States

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San Antonio, Texas, 78205, United States

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San Antonio, Texas, 78215, United States

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San Antonio, Texas, 78229, United States

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San Antonio, Texas, United States

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Orem, Utah, United States

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Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Vancouver, British Columbia, Canada

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Saint John, New Brunswick, Canada

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London, Ontario, Canada

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Thornhill, Ontario, Canada

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Vaughan, Ontario, Canada

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Pointe-Claire, Quebec, Canada

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Békéscsaba, Hungary

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Gyula, Hungary

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Komárom, Hungary

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Szekszárd, Hungary

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Vác, Hungary

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Hyderabad, Andhra Pradesh, India

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Secunderabad, Andhra Pradesh, India

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Guwahati, Assam, India

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Bangalore, Karnataka, 560002, India

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Bangalore, Karnataka, 560054, India

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Aurangabad, Maharashtra, India

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Nagpur, Maharashtra, India

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Nashik, Maharashtra, India

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Pune, Maharashtra, India

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Jaipur, Rajasthan, India

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Chennai, Tamil Nadu, India

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Madurai, Tamil Nadu, India

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Lucknow, Uttar Pradesh, 226003, India

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Lucknow, Uttar Pradesh, India

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Daugavpils, Latvia

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Riga, LV-1002, Latvia

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Riga, LV-1005, Latvia

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Riga, LV-1006, Latvia

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Riga, LV-1010, Latvia

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Valmiera, Latvia

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Ventspils, LV-3601, Latvia

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Ventspils, Latvia

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Bialystok, Poland

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Sopot, Poland

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Warsaw, Poland

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Wroclaw, Poland

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Related Publications (1)

• 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.

  PMID: 26572233 BACKGROUND

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Information
• Organization: AMAG Pharmaceuticals, Inc.

CTInterest@covispharma.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: July 27, 2010
• Primary Completion: September 24, 2012
• Study Completion: April 23, 2013
• Last Updated: April 21, 2022
• Results First Posted: June 11, 2018

Record last verified: 2022-03

Locations

HU (5); US (103); IN (14); CA (6); LA (8); PL (4)