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

March 31, 2022 updated by: AMAG Pharmaceuticals, Inc.

A Phase III, Open-Label Extension Trial of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

634

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Clinical Trial Site
    • New Brunswick
      • Saint John, New Brunswick, Canada
        • Clinical Trial Site
    • Ontario
      • London, Ontario, Canada
        • Clinical Trial Site
      • Thornhill, Ontario, Canada
        • Clinical Trial Site
      • Vaughan, Ontario, Canada
        • Clinical Trial Site
    • Quebec
      • Pointe-Claire, Quebec, Canada
        • Clinical Trial Site
  • Hungary
      • Bekescsaba, Hungary
        • Clinical Trial Site
      • Gyula, Hungary
        • Clinical Trial Site
      • Komárom, Hungary
        • Clinical Trial Site
      • Szekszárd, Hungary
        • Clinical Trial Site
      • Vác, Hungary
        • Clinical Trial Site
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Clinical Trial Site
      • Secunderabad, Andhra Pradesh, India
        • Clinical Trial Site
    • Assam
      • Guwahati, Assam, India
        • Clinical Trial Site
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Clinical Trial Site
      • Bangalore, Karnataka, India, 560054
        • Clinical Trial Site
    • Maharashtra
      • Aurangabad, Maharashtra, India
        • Clinical Trial Site
      • Nagpur, Maharashtra, India
        • Clinical Trial Site
      • Nashik, Maharashtra, India
        • Clinical Trial Site
      • Pune, Maharashtra, India
        • Clinical Trial Site
    • Rajasthan
      • Jaipur, Rajasthan, India
        • Clinical Trial Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • Clinical Trial Site
      • Madurai, Tamil Nadu, India
        • Clinical Trial Site
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • Clinical Trial Site
      • Lucknow, Uttar Pradesh, India
        • Clinical Trial Site
  • Latvia
      • Daugavpils, Latvia
        • Clinical Trial Site
      • Riga, Latvia, LV-1002
        • Clinical Trial Site
      • Riga, Latvia, LV-1005
        • Clinical Trial Site
      • Riga, Latvia, LV-1006
        • Clinical Trial Site
      • Riga, Latvia, LV-1010
        • Clinical Trial Site
      • Valmiera, Latvia
        • Clinical Trial Site
      • Ventspils, Latvia, LV-3601
        • Clinical Trial Site
      • Ventspils, Latvia
        • Clinical Trial Site
  • Poland
      • Białystok, Poland
        • Clinical Trial Site
      • Sopot, Poland
        • Clinical Trial Site
      • Warszawa, Poland
        • Clinical Trial Site
      • Wrocław, Poland
        • Clinical Trial Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Clinical Trial Site
      • Mobile, Alabama, United States
        • Clinical Trial Site
      • Montgomery, Alabama, United States, 36106
        • Clinical Trial Site
      • Montgomery, Alabama, United States, 36116
        • Clinical Trial Site
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Clinical Trial Site
      • Phoenix, Arizona, United States, 85015
        • Clinical Trial Site
      • Tucson, Arizona, United States, 85710
        • Clinical Trial Site
      • Tucson, Arizona, United States, 85712
        • Clinical Trial Site
    • California
      • Anaheim, California, United States
        • Clinical Trial Site
      • Bakersfield, California, United States
        • Clinical Trial Site
      • Buena Park, California, United States
        • Clinical Trial Site
      • Colton, California, United States
        • Clinical Trial Site
      • Los Angeles, California, United States, 90036
        • Clinical Trial Site
      • Los Angeles, California, United States, 90057
        • Clinical Trial Site
      • Los Angeles, California, United States
        • Clinical Trial Site
      • Mission Hills, California, United States
        • Clinical Trial Site
      • Orange, California, United States
        • Clinical Trial Site
      • San Diego, California, United States, 92103
        • Clinical Trial Site
      • San Diego, California, United States, 92123
        • Clinical Trial Site
      • San Diego, California, United States, 92121
        • Clinical Trial Site
    • Colorado
      • Pueblo, Colorado, United States
        • Clinical Trial Site
    • Connecticut
      • Bristol, Connecticut, United States
        • Clinical Trial Site
      • Groton, Connecticut, United States
        • Clinical Trial Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Clinical Trial Site
      • Boynton Beach, Florida, United States, 33472
        • Clinical Trial Site
      • Clearwater, Florida, United States, 33759
        • Clinical Trial Site
      • Clearwater, Florida, United States, 33756
        • Clinical Trial Site
      • Hialeah, Florida, United States
        • Clinical Trial Site
      • Holiday, Florida, United States
        • Clinical Trial Site
      • Inverness, Florida, United States
        • Clinical Trial Site
      • Margate, Florida, United States
        • Clinical Trial Site
      • Miami, Florida, United States, 33126
        • Clinical Trial Site
      • Miami, Florida, United States, 33143
        • Clinical Trial Site
      • Miami, Florida, United States, 33144
        • Clinical Trial Site
      • Miami, Florida, United States, 33175
        • Clinical Trial Site
      • Miami, Florida, United States, 33135
        • Clinical Trial Site
      • Miami Lakes, Florida, United States
        • Clinical Trial Site
      • Naples, Florida, United States
        • Clinical Trial Site
      • Vero Beach, Florida, United States
        • Clinical Trial Site
      • West Palm Beach, Florida, United States
        • Clinical Trial Site
      • Zephyrhills, Florida, United States
        • Clinical Trial Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Clinical Trial Site
      • Atlanta, Georgia, United States, 30342
        • Clinical Trial Site
      • Atlanta, Georgia, United States, 30312
        • Clinical Trial Site
      • Decatur, Georgia, United States
        • Clinical Trial Site
      • Dublin, Georgia, United States
        • Clinical Trial Site
      • Sandy Springs, Georgia, United States
        • Clinical Trial Site
      • Stockbridge, Georgia, United States
        • Clinical Trial Site
    • Illinois
      • Aurora, Illinois, United States
        • Clinical Trial Site
      • Chicago, Illinois, United States, 60616
        • Clinical Trial Site
      • Skokie, Illinois, United States, 60076
        • Clinical Trial Site
      • Skokie, Illinois, United States
        • Clinical Trial Site
      • Springfield, Illinois, United States
        • Clinical Trial Site
    • Kansas
      • Wichita, Kansas, United States
        • Clinical Trial Site
    • Louisiana
      • New Orleans, Louisiana, United States
        • Clinical Trial Site
    • Maryland
      • Bethesda, Maryland, United States
        • Clinical Trial Site
      • Hollywood, Maryland, United States
        • Clinical Trial Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Clinical Trial Site
      • Bay City, Michigan, United States
        • Clinical Trial Site
      • Wyoming, Michigan, United States
        • Clinical Trial Site
    • Missouri
      • Kansas City, Missouri, United States
        • Clinical Trial Site
    • Nevada
      • Las Vegas, Nevada, United States
        • Clinical Trial Site
    • New Jersey
      • Lawrenceville, New Jersey, United States
        • Clinical Trial Site
      • Neptune, New Jersey, United States
        • Clinical Trial Site
      • Plainsboro, New Jersey, United States
        • Clinical Trial Site
      • Voorhees, New Jersey, United States
        • Clinical Trial Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Clinical Trial Site
    • New York
      • Brooklyn, New York, United States
        • Clinical Trial Site
      • New York, New York, United States, 10038
        • Clinical Trial Site
    • North Carolina
      • Raleigh, North Carolina, United States
        • Clinical Trial Site
      • Winston-Salem, North Carolina, United States
        • Clinical Trial Site
    • Ohio
      • Canton, Ohio, United States
        • Clinical Trial Site
      • Carlisle, Ohio, United States
        • Clinical Trial Site
      • Cincinnati, Ohio, United States, 45224
        • Clinical Trial Site
      • Cincinnati, Ohio, United States, 45242
        • Clinical Trial Site
      • Columbus, Ohio, United States, 43231
        • Clinical Trial Site
      • Marion, Ohio, United States, 43302
        • Clinical Trial Site
      • Marion, Ohio, United States
        • Clinical Trial Site
      • Mentor, Ohio, United States
        • Clinical Trial Site
      • Middletown, Ohio, United States
        • Clinical Trial Site
      • Zanesville, Ohio, United States
        • Clinical Trial Site
    • Oklahoma
      • Norman, Oklahoma, United States
        • Clinical Trial Site
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
        • Clinical Trial Site
      • Levittown, Pennsylvania, United States
        • Clinical Trial Site
    • South Carolina
      • Columbia, South Carolina, United States
        • Clinical Trial Site
      • Greer, South Carolina, United States
        • Clinical Trial Site
      • Myrtle Beach, South Carolina, United States
        • Clinical Trial Site
      • North Charleston, South Carolina, United States
        • Clinical Trial Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Clinical Trial Site
    • Texas
      • Arlington, Texas, United States
        • Clinical Trial Site
      • Dallas, Texas, United States
        • Clinical Trial Site
      • Houston, Texas, United States, 77030
        • Clinical Trial Site
      • Houston, Texas, United States, 77074
        • Clinical Trial Site
      • Houston, Texas, United States
        • Clinical Trial Site
      • Laredo, Texas, United States
        • Clinical Trial Site
      • Longview, Texas, United States
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78205
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78229
        • Clinical Trial Site
      • San Antonio, Texas, United States
        • Clinical Trial Site
      • San Antonio, Texas, United States, 78215
        • Clinical Trial Site
    • Utah
      • Orem, Utah, United States
        • Clinical Trial Site
    • Virginia
      • Chesapeake, Virginia, United States
        • Clinical Trial Site
      • Norfolk, Virginia, United States
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ferumoxytol
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
IV Ferumoxytol
Other Names:
  • Feraheme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change In Hemoglobin From TP Baseline To TP Week 5 Following The First Course Of Ferumoxytol
Time Frame: TP Baseline (Day 1), TP Week 5

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

Mean change in hemoglobin from TP Baseline to TP Week 5 following each course of ferumoxytol after the first course was calculated for each participant as:

Hemoglobin Change = Hemoglobin (TP Week 5) - Hemoglobin (TP Baseline) The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
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
Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Proportion of participants with an increase in hemoglobin ≥2.0 g/dL at any time from TP Baseline to TP Week 5 following each course of ferumoxytol. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
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
Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Proportion 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. The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
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
Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Mean change in TSAT 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
Time Frame: TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3

The FACIT-Fatigue questionnaire is a 13-item questionnaire designed and validated to specifically assess the presence and impact of treatment on fatigue and related symptoms, such as tiredness, on health-related quality of life in anemic participants with cancer. The questionnaire has 13 items, each measured on a 4-point Likert scale. Scoring ranges from 0 (the most fatigued) to 52 (the least fatigued) points, with higher scores representing better functioning or less fatigue.

Mean change in FACIT-Fatigue questionnaire from TP Baseline to TP Week 5 following each course of ferumoxytol was calculated as:

FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).

TP Baseline was the most recent value measured on/after the screening or the closest monthly evaluation visit prior to Day 1 dosing in each course.

If the TP Week 5 FACIT-Fatigue Score value was missing, the change from TP Baseline was conservatively imputed as zero.
TP Baseline (Day 1), TP Week 5 for Courses 1, 2, and 3
Time To Hemoglobin Increase Of ≥2.0 g/dL Or To A Hemoglobin Level Of ≥12.0 g/dL From Baseline
Time Frame: TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3

Days to event was defined as the days from Baseline to the first time the participant met the criteria. Participants without any post-Baseline study visits were not included in this analysis.

The first course of treatment with ferumoxytol for participants who had previously received placebo in AMAG-FER-IDA-301 was considered Course 1. The first course of treatment with ferumoxytol for participants who had previously received ferumoxytol in AMAG-FER-IDA-301 was considered Course 2; subsequent treatment courses were serially numbered.
TP Baseline (Day 1) up to TP Week 5 for Courses 1, 2, and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMAG Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2010

Primary Completion (Actual)

September 24, 2012

Study Completion (Actual)

April 23, 2013

Study Registration Dates

First Submitted

April 29, 2010

First Submitted That Met QC Criteria

April 30, 2010

First Posted (Estimate)

May 3, 2010

Study Record Updates

Last Update Posted (Actual)

April 21, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMAG-FER-IDA-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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