A Trial Comparing Ferumoxytol With Placebo for the Treatment of Iron Deficiency Anemia

Iron Deficiency Anemia Clinical Trial

Official title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01114139
• Other study ID #: AMAG-FER-IDA-301
• Status: Completed
• Phase: Phase 3
• Start date: June 19, 2010
• Est. completion date: October 22, 2012

Study information

• Verified date: March 2022
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared with placebo for the treatment of iron deficiency anemia (IDA).

Description:

This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical study evaluated the safety and efficacy of ferumoxytol compared with placebo for the treatment of IDA, specifically in adult patients with IDA who have a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. The effect of ferumoxytol on hemoglobin, iron parameters and patient reported outcomes (PROs) compared with placebo was evaluated. Investigators were blinded to key laboratory parameters that could potentially unblind the treatment arms of the study, eg, hemoglobin [Hgb], hematocrit [Hct], iron, ferritin, total iron binding capacity [TIBC], and transferrin saturation [TSAT], and neither the Investigators nor the subjects were aware of their treatment assignment, hemoglobin or other laboratory values.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 812
• Est. completion date: October 22, 2012
• Est. primary completion date: February 27, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria include:

1. Males and females =18 years of age

2. Participants with IDA defined as having:

1. Hemoglobin <10.0 g/deciliter (dL)

2. Transferrin saturation <20%

3. Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used

4. Female participants of childbearing potential who are sexually active must be on an effective method of birth control for at least 1 month prior to screening and agree to remain on birth control until completion of participation in the study

Key Exclusion Criteria include:

1. History of allergy to IV iron

2. Allergy to two or more classes of drugs

3. Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute/1.73 m^2

4. Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test

5. Hemoglobin =7.0 g/dL

6. Serum ferritin >600 nanograms/mL

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Iron Deficiency Anemia

Intervention

Drug:
• Ferumoxytol
IV Ferumoxytol

Other:
• Placebo
IV Placebo

Locations

Country	Name	City	State
Canada	Clinical Trial Site	London	Ontario
Canada	Clinical Trial Site	Pointe-Claire	Quebec
Canada	Clinical Trial Site	Saint John	New Brunswick
Canada	Clinical Trial Site	Scarborough	Ontario
Canada	Clinical Trial Site	Thornhill	Ontario
Canada	Clinical Trial Site	Vancouver	British Columbia
Canada	Clinical Trial Site	Vaughan	Ontario
Hungary	Clinical Trial Site	Békéscsaba
Hungary	Clinical Trial Site	Gyula
Hungary	Clinical Trial Site	Komárom
Hungary	Clinical Trial Site	Szekszárd
Hungary	Clinical Trial Site	Vác
India	Clinical Trial Site	Aurangabad	Maharashtra
India	Clinical Trial Site	Bangalore	Karnataka
India	Clinical Trial Site	Bangalore	Karnataka
India	Clinical Trial Site	Chennai	Tamil Nadu
India	Clinical Trial Site	Chennai	Tamil Nadu
India	Clinical Trial Site	Coimbatore	Tamil Nadu
India	Clinical Trial Site	Guwahati	Assam
India	Clinical Trial Site	Hyderabad	Andhra Pradesh
India	Clinical Trial Site	Jaipur	Rajasthan
India	Clinical Trial Site	Jaipur	Rajasthan
India	Clinical Trial Site	Lucknow	Uttar Pradesh
India	Clinical Trial Site	Lucknow	Uttar Pradesh
India	Clinical Trial Site	Madurai	Tamil Nadu
India	Clinical Trial Site	Mangalore	Karnataka
India	Clinical Trial Site	Nagpur	Maharashtra
India	Clinical Trial Site	Nashik	Maharashtra
India	Clinical Trial Site	Pune	Maharashtra
India	Clinical Trial Site	Secunderabad	Andhra Pradesh
India	Clinical Trial Site	Visakhapatnam	Andhrapradesh
Latvia	Clinical Trial Site	Daugavpils
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Riga
Latvia	Clinical Trial Site	Valmiera
Latvia	Clinical Trial Site	Ventspils
Latvia	Clinical Trial Site	Ventspils
Poland	Clinical Trial Site	Bialystok
Poland	Clinical Trial Site	Sopot
Poland	Clinical Trial Site	Warszawa
Poland	Clinical Trial Site	Warszawa
Poland	Clinical Trial Site	Wroclaw
Poland	Clinical Trial Site	Zgierz
United States	Clinical Trial Site	Akron	Ohio
United States	Clinical Trial Site	Albuquerque	New Mexico
United States	Clinical Trial Site	Alhambra	California
United States	Clinical Trial Site	Anaheim	California
United States	Clinical Trial Site	Arlington	Texas
United States	Clinical Trial Site	Atlanta	Georgia
United States	Clinical Trial Site	Atlanta	Georgia
United States	Clinical Trial Site	Atlanta	Georgia
United States	Clinical Trial Site	Aurora	Illinois
United States	Clinical Trial Site	Bakersfield	California
United States	Clinical Trial Site	Bay City	Michigan
United States	Clinical Trial Site	Bay City	Michigan
United States	Clinical Trial Site	Beavercreek	Ohio
United States	Clinical Trial Site	Bethesda	Maryland
United States	Clinical Trial Site	Birmingham	Alabama
United States	Clinical Trial Site	Bismarck	North Dakota
United States	Clinical Trial Site	Boynton Beach	Florida
United States	Clinical Trial Site	Boynton Beach	Florida
United States	Clinical Trial Site	Bristol	Connecticut
United States	Clinical Trial Site	Brooklyn	New York
United States	Clinical Trial Site	Buena Park	California
United States	Clinical Trial Site	Canton	Ohio
United States	Clinical Trial Site	Carlisle	Ohio
United States	Clinical Trial Site	Chesapeake	Virginia
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Chicago	Illinois
United States	Clinical Trial Site	Cincinnati	Ohio
United States	Clinical Trial Site	Cincinnati	Ohio
United States	Clinical Trial Site	Clearwater	Florida
United States	Clinical Trial Site	Clearwater	Florida
United States	Clinical Trial Site	Colton	California
United States	Clinical Trial Site	Columbia	South Carolina
United States	Clinical Trial Site	Columbus	Ohio
United States	Clinical Trial Site	Columbus	Georgia
United States	Clinical Trial Site	Dallas	Texas
United States	Clinical Trial Site	Dayton	Ohio
United States	Clinical Trial Site	Decatur	Georgia
United States	Clinical Trial Site	Dublin	Georgia
United States	Clinical Trial Site	East Providence	Rhode Island
United States	Clinical Trial Site	Evergreen Park	Illinois
United States	Clinical Trial Site	Fresno	California
United States	Clinical Trial Site	Glendale	California
United States	Clinical Trial Site	Goshen	New York
United States	Clinical Trial Site	Green Valley	Arizona
United States	Clinical Trial Site	Greer	South Carolina
United States	Clinical Trial Site	Groton	Connecticut
United States	Clinical Trial Site	Hialeah	Florida
United States	Clinical Trial Site	Holiday	Florida
United States	Clinical Trial Site	Hollywood	Maryland
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Houston	Texas
United States	Clinical Trial Site	Indianapolis	Indiana
United States	Clinical Trial Site	Inverness	Florida
United States	Clinical Trial Site	Jenkintown	Pennsylvania
United States	Clinical Trial Site	Kansas City	Missouri
United States	Clinical Trial Site	Laguna Hills	California
United States	Clinical Trial Site	Laguna Hills	California
United States	Clinical Trial Site	Lakewood	California
United States	Clinical Trial Site	Laredo	Texas
United States	Clinical Trial Site	Las Vegas	Nevada
United States	Clinical Trial Site	Lawrenceville	New Jersey
United States	Clinical Trial Site	Levittown	Pennsylvania
United States	Clinical Trial Site	Longview	Texas
United States	Clinical Trial Site	Los Angeles	California
United States	Clinical Trial Site	Los Angeles	California
United States	Clinical Trial Site	Los Angeles	California
United States	Clinical Trial Site	Margate	Florida
United States	Clinical Trial Site	Marion	Ohio
United States	Clinical Trial Site	Marion	Ohio
United States	Clinical Trial Site	Mentor	Ohio
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami	Florida
United States	Clinical Trial Site	Miami Lakes	Florida
United States	Clinical Trial Site	Middletown	Ohio
United States	Clinical Trial Site	Mission Hills	California
United States	Clinical Trial Site	Mobile	Alabama
United States	Clinical Trial Site	Montgomery	Alabama
United States	Clinical Trial Site	Montgomery	Alabama
United States	Clinical Trial Site	Myrtle Beach	South Carolina
United States	Clinical Trial Site	Naples	Florida
United States	Clinical Trial Site	Nashville	Tennessee
United States	Clinical Trial Site	Neptune	New Jersey
United States	Clinical Trial Site	New Orleans	Louisiana
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	New York	New York
United States	Clinical Trial Site	Newark	Delaware
United States	Clinical Trial Site	Norfolk	Virginia
United States	Clinical Trial Site	Norman	Oklahoma
United States	Clinical Trial Site	North Charleston	South Carolina
United States	Clinical Trial Site	Ocala	Florida
United States	Clinical Trial Site	Orange	California
United States	Clinical Trial Site	Orangeburg	South Carolina
United States	Clinical Trial Site	Orem	Utah
United States	Clinical Trial Site	Phoenix	Arizona
United States	Clinical Trial Site	Phoenix	Arizona
United States	Clinical Trial Site	Plainsboro	New Jersey
United States	Clinical Trial Site	Prince Frederick	Maryland
United States	Clinical Trial Site	Pueblo	Colorado
United States	Clinical Trial Site	Raleigh	North Carolina
United States	Clinical Trial Site	Rapid City	South Dakota
United States	Clinical Trial Site	Rome	Georgia
United States	Clinical Trial Site	Saginaw	Michigan
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Antonio	Texas
United States	Clinical Trial Site	San Diego	California
United States	Clinical Trial Site	San Diego	California
United States	Clinical Trial Site	San Diego	California
United States	Clinical Trial Site	Sandy Springs	Georgia
United States	Clinical Trial Site	Savannah	Georgia
United States	Clinical Trial Site	Skokie	Illinois
United States	Clinical Trial Site	Skokie	Illinois
United States	Clinical Trial Site	Somerville	New Jersey
United States	Clinical Trial Site	Spring	Texas
United States	Clinical Trial Site	Springfield	Illinois
United States	Clinical Trial Site	Stockbridge	Georgia
United States	Clinical Trial Site	Tucson	Arizona
United States	Clinical Trial Site	Tucson	Arizona
United States	Clinical Trial Site	Vero Beach	Florida
United States	Clinical Trial Site	Voorhees	New Jersey
United States	AMAG Pharmaceuticals, Inc.	Waltham	Massachusetts
United States	Clinical Trial Site	Wellington	Florida
United States	Clinical Trial Site	Wellington	Florida
United States	Clinical Trial Site	West Palm Beach	Florida
United States	Clinical Trial Site	Wichita	Kansas
United States	Clinical Trial Site	Wilmington	North Carolina
United States	Clinical Trial Site	Winston-Salem	North Carolina
United States	Clinical Trial Site	Winter Park	Florida
United States	Clinical Trial Site	Wyoming	Michigan
United States	Clinical Trial Site	Zanesville	Ohio
United States	Clinical Trial Site	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AMAG Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Hungary,  India,  Latvia,  Poland, 

References & Publications (1)

Vadhan-Raj S, Strauss W, Ford D, Bernard K, Boccia R, Li J, Allen LF. Efficacy and safety of IV ferumoxytol for adults with iron deficiency anemia previously unresponsive to or unable to tolerate oral iron. Am J Hematol. 2014 Jan;89(1):7-12. doi: 10.1002/ajh.23582. Epub 2013 Sep 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants Who Achieved A =2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5	Participants who achieved a =2.0 g/dL increase in hemoglobin at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5.; Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants with no post-Baseline hemoglobin values were classified as not achieving a =2.0 g/dL increase.; Statistical analysis was performed for data up to Week 5 only.	Baseline (Day 1) through Week 5
Secondary	Mean Change In Hemoglobin From Baseline To Week 5	Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 hemoglobin value was missing, the change from Baseline was imputed to be zero. Participants without any post-Baseline hemoglobin values were treated as non-responders.	Baseline (Day 1), Week 5
Secondary	Participants Achieving A Hemoglobin Level =12.0 g/dL At Any Time From Baseline To Week 5	Participants who achieved a =12.0 g/dL hemoglobin level at any time from Baseline up to Week 5 are presented. Increase in hemoglobin at any time from Baseline up to Week 5 was calculated for each participant based on: Hemoglobin Change = Hemoglobin (Week X) - Hemoglobin (Baseline), where Week X was any post-Baseline visit up to and including Week 5. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. Participants without any post-Baseline hemoglobin values were treated as non-responders.	Baseline (Day 1) through Week 5
Secondary	Mean Change In TSAT From Baseline To Week 5	Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).; TSAT, measured as a percentage, was part of the iron panel laboratory evaluations. Of the transferrin available to bind iron, this value indicates how much serum iron is bound. For example, a value of 20% means that 20% of iron-binding sites of transferrin are being occupied by iron. Baseline was defined as the Day 1 value (prior to injection of study drug). The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 TSAT value was missing, the change from Baseline was imputed to be zero.	Baseline (Day 1), Week 5
Secondary	Mean Change In Functional Assessment Of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5	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 Score from Baseline to Week 5 was calculated for each participant as: FACIT-Fatigue Score Change = FACIT-Fatigue Score (Week 5) - FACIT-Fatigue Score (Baseline).; Baseline was defined as the Day 1 value (prior to first dose of study drug).The screening or most recent value prior to Day 1 was used for any participant with missing Day 1 information. If the Week 5 FACIT-Fatigue Score value was missing, the change from Baseline was imputed to be zero.	Baseline (Day 1), Week 5
Secondary	Time To Hemoglobin Increase Of =2.0 g/dL Or A Hemoglobin Value Of =12.0 g/dL From Baseline	The time to hemoglobin increase of =2.0 g/dL or hemoglobin value of =12.0 g/dL was defined as the days from Baseline (Day 1) to the first time the participant had an increase in hemoglobin of =2.0 g/dL or hemoglobin value of =12.0 g/dL, and was calculated using a Kaplan-Meier curve. Participants who did not have a hemoglobin increase of =2.0 g/dL or to a hemoglobin level =12.0 g/dL were censored at their last visit day. Participants without any post-Baseline study visits were not included.	From Baseline (Day 1) up to Week 5