Back to resultsA Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ferumoxytol
Iron Sucrose
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring Iron deficiency anemia, Feraheme, ferumoxytol, iron sucrose, Venofer, IDA
Eligibility Criteria
Key Inclusion Criteria include:
- Males and females ≥18 years of age
Participants with IDA defined as having:
- Hemoglobin <10.0 g/deciliter (dL)
- Transferrin saturation (TSAT) <20%
- Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
- 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:
- History of allergy to IV iron
- Allergy to two or more classes of drugs
- Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2)
- Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
- Hemoglobin ≤7.0 g/dL
- Serum ferritin >600 nanogram/mL
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferumoxytol
Iron Sucrose
Arm Description
Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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 5) - Hemoglobin (Baseline).
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 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.
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).
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.
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.
Time To Hemoglobin Increase Of ≥2.0 g/dL Or 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.
Full Information
NCT ID
NCT01114204
First Posted
April 29, 2010
Last Updated
March 31, 2022
Sponsor
AMAG Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01114204
Brief Title
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Official Title
A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
August 10, 2010 (Actual)
Primary Completion Date
November 9, 2011 (Actual)
Study Completion Date
June 25, 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMAG Pharmaceuticals, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
Iron deficiency anemia, Feraheme, ferumoxytol, iron sucrose, Venofer, IDA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
605 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferumoxytol
Arm Type
Experimental
Arm Description
Participants received a total of 2 doses of IV ferumoxytol 510 milligrams (mg) (17 milliliters [mL]). The first IV 510 mg dose was administered on Day 1 (Baseline) and second dose 2 to 8 (5±3) days after the first dose, for a total cumulative dose of 1.02 grams (g).
Arm Title
Iron Sucrose
Arm Type
Active Comparator
Arm Description
Participants received an IV injection or infusion of iron sucrose 200 mg (10 mL) on Day 1 (Baseline) and on 4 other non-consecutive days over a 14-day period, for a total cumulative dose of 1.0 g. Participants receiving their first ever exposure to IV iron sucrose, received a test dose on Day 1 prior to receiving the remainder of the first dose, as prescribed in the package insert for some countries.
Intervention Type
Drug
Intervention Name(s)
Ferumoxytol
Other Intervention Name(s)
Feraheme
Intervention Description
IV Ferumoxytol
Intervention Type
Drug
Intervention Name(s)
Iron Sucrose
Other Intervention Name(s)
Venofer
Intervention Description
IV Iron Sucrose
Primary Outcome Measure Information:
Title
Participants Who Achieved A ≥2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
Description
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.
Time Frame
Baseline (Day 1) through Week 5
Secondary Outcome Measure Information:
Title
Mean Change In Hemoglobin From Baseline To Week 5
Description
Mean change in hemoglobin from Baseline to Week 5 was calculated for each participant as: Hemoglobin Change = Hemoglobin (Week 5) - Hemoglobin (Baseline).
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.
Time Frame
Baseline (Day 1), Week 5
Title
Participants Achieving A Hemoglobin Level ≥12.0 g/dL At Any Time From Baseline To Week 5
Description
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.
Time Frame
Baseline (Day 1) through Week 5
Title
Mean Change In TSAT From Baseline To Week 5
Description
Mean change in TSAT from Baseline to Week 5 was calculated for each participant as: TSAT Change = TSAT (Week 5) - TSAT (Baseline).
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.
Time Frame
Baseline (Day 1), Week 5
Title
Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
Description
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.
Time Frame
Baseline (Day 1), Week 5
Title
Time To Hemoglobin Increase Of ≥2.0 g/dL Or Hemoglobin Value Of ≥12.0 g/dL From Baseline
Description
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.
Time Frame
From Baseline (Day 1) up to Week 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria include:
Males and females ≥18 years of age
Participants with IDA defined as having:
Hemoglobin <10.0 g/deciliter (dL)
Transferrin saturation (TSAT) <20%
Participants who have a history of unsatisfactory oral iron therapy or in whom oral iron cannot be used
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:
History of allergy to IV iron
Allergy to two or more classes of drugs
Participants on dialysis or with an estimated glomerular filtration rate <30 mL/minute(min)/1.73 square meter (m^2)
Female participants who are pregnant, intend to become pregnant, are breastfeeding, within 2 weeks postpartum, or have a positive serum/urine pregnancy test
Hemoglobin ≤7.0 g/dL
Serum ferritin >600 nanogram/mL
Facility Information:
Facility Name
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City
Adelaide
Country
Australia
Facility Name
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City
Ballarat
Country
Australia
Facility Name
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City
Concord
Country
Australia
Facility Name
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City
Five Dock
Country
Australia
Facility Name
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City
Gosford
Country
Australia
Facility Name
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City
Kingswood
Country
Australia
Facility Name
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City
Parkville
Country
Australia
Facility Name
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City
La Tronche
Country
France
Facility Name
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City
Berlin
Country
Germany
Facility Name
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City
Frankfurt
ZIP/Postal Code
60322
Country
Germany
Facility Name
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City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
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City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
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City
Mainz
ZIP/Postal Code
D-55116
Country
Germany
Facility Name
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City
Siegen
Country
Germany
Facility Name
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City
Wilhelmshaven
Country
Germany
Facility Name
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City
Békéscsaba
Country
Hungary
Facility Name
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City
Gyula
Country
Hungary
Facility Name
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City
Komárom
Country
Hungary
Facility Name
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City
Miskolc
Country
Hungary
Facility Name
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City
Szekszárd
Country
Hungary
Facility Name
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City
Szolnok
Country
Hungary
Facility Name
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City
Vác
Country
Hungary
Facility Name
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City
Zalaegerszeg
Country
Hungary
Facility Name
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City
Padova
Country
Italy
Facility Name
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City
Rozzano
Country
Italy
Facility Name
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City
Cheonan
Country
Korea, Republic of
Facility Name
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City
Daegu
Country
Korea, Republic of
Facility Name
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City
Incheon
ZIP/Postal Code
400-711
Country
Korea, Republic of
Facility Name
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City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
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City
Seoul
ZIP/Postal Code
110-774
Country
Korea, Republic of
Facility Name
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City
Seoul
ZIP/Postal Code
134-701
Country
Korea, Republic of
Facility Name
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City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
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City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
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City
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
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City
Seoul
Country
Korea, Republic of
Facility Name
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City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of
Facility Name
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City
Suwon
ZIP/Postal Code
443-721
Country
Korea, Republic of
Facility Name
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City
Daugavpils
Country
Latvia
Facility Name
For additional information regarding investigative sites for this trial, contact 1-617-498-3300 Mon-Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
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City
Riga
ZIP/Postal Code
LV-1005
Country
Latvia
Facility Name
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City
Riga
ZIP/Postal Code
LV-1006
Country
Latvia
Facility Name
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City
Riga
ZIP/Postal Code
LV-1010
Country
Latvia
Facility Name
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City
Riga
ZIP/Postal Code
LV-1013
Country
Latvia
Facility Name
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City
Ventspils
ZIP/Postal Code
LV-3601
Country
Latvia
Facility Name
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City
Ventspils
Country
Latvia
Facility Name
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City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Facility Name
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City
Kaunas
ZIP/Postal Code
LT-49449
Country
Lithuania
Facility Name
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City
Kaunas
ZIP/Postal Code
LT-50009
Country
Lithuania
Facility Name
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City
Kaunas
ZIP/Postal Code
LT-50185
Country
Lithuania
Facility Name
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City
Klaipėda
Country
Lithuania
Facility Name
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City
Vilnius
ZIP/Postal Code
LT-03215
Country
Lithuania
Facility Name
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City
Vilnius
ZIP/Postal Code
LT-08661
Country
Lithuania
Facility Name
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City
Šiauliai
Country
Lithuania
Facility Name
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City
Białystok
Country
Poland
Facility Name
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City
Katowice
Country
Poland
Facility Name
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City
Kraków
Country
Poland
Facility Name
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City
Sopot
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
02-341
Country
Poland
Facility Name
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City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
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City
Wrocław
Country
Poland
Facility Name
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City
Zgierz
Country
Poland
Facility Name
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City
Łęczyca
Country
Poland
Facility Name
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City
Braşov
Country
Romania
Facility Name
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City
Bucharest
ZIP/Postal Code
011422
Country
Romania
Facility Name
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City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
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City
Iaşi
Country
Romania
Facility Name
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City
Suceava
Country
Romania
Facility Name
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City
Timişoara
ZIP/Postal Code
300158
Country
Romania
Facility Name
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City
Timişoara
ZIP/Postal Code
300593
Country
Romania
Facility Name
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City
Târgu-Mureş
ZIP/Postal Code
540136
Country
Romania
Facility Name
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City
Târgu-Mureş
ZIP/Postal Code
540461
Country
Romania
Facility Name
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City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
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City
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
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City
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
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City
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
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City
Roodepoort
Country
South Africa
Facility Name
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City
Stellenbosch
Country
South Africa
Facility Name
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City
Barcelona
Country
Spain
Facility Name
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City
Manresa
Country
Spain
Facility Name
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City
Santa Cruz De Tenerife
Country
Spain
Facility Name
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City
Sevilla
Country
Spain
Facility Name
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City
Cherkasy
Country
Ukraine
Facility Name
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City
Chernivtsi
Country
Ukraine
Facility Name
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City
Donetsk
ZIP/Postal Code
83045
Country
Ukraine
Facility Name
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City
Donetsk
ZIP/Postal Code
83114
Country
Ukraine
Facility Name
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City
Ivano-Frankivsk
Country
Ukraine
Facility Name
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City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
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City
Kyiv
ZIP/Postal Code
01034
Country
Ukraine
Facility Name
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City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
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City
Kyiv
ZIP/Postal Code
04112
Country
Ukraine
Facility Name
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City
Odessa
Country
Ukraine
Facility Name
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City
Simferopol
Country
Ukraine
Facility Name
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City
Vinnytsya
Country
Ukraine
Facility Name
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City
Zaporizhzhya
Country
Ukraine
Facility Name
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City
Cambridge
Country
United Kingdom
Facility Name
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City
London
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27462400
Citation
Strauss WE, Dahl NV, Li Z, Lau G, Allen LF. Ferumoxytol versus iron sucrose treatment: a post-hoc analysis of randomized controlled trials in patients with varying renal function and iron deficiency anemia. BMC Hematol. 2016 Jul 26;16:20. doi: 10.1186/s12878-016-0060-x. eCollection 2016.
Results Reference
background
PubMed Identifier
24639149
Citation
Hetzel D, Strauss W, Bernard K, Li Z, Urboniene A, Allen LF. A Phase III, randomized, open-label trial of ferumoxytol compared with iron sucrose for the treatment of iron deficiency anemia in patients with a history of unsatisfactory oral iron therapy. Am J Hematol. 2014 Jun;89(6):646-50. doi: 10.1002/ajh.23712.
Results Reference
background
Learn more about this trial
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
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