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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01114204
Registration number
NCT01114204
Ethics application status
Date submitted
29/04/2010
Date registered
3/05/2010
Date last updated
21/04/2022
Titles & IDs
Public title
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
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Scientific title
A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
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Secondary ID [1]
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AMAG-FER-IDA-302
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anemia
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Condition category
Condition code
Blood
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Anaemia
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Diet and Nutrition
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Other diet and nutrition disorders
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ferumoxytol
Treatment: Drugs - Iron Sucrose
Experimental: Ferumoxytol - 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).
Active comparator: Iron Sucrose - 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.
Treatment: Drugs: Ferumoxytol
IV Ferumoxytol
Treatment: Drugs: Iron Sucrose
IV Iron Sucrose
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Participants Who Achieved A =2.0 g/dL Increase In Hemoglobin At Any Time From Baseline To Week 5
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1) through Week 5
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Secondary outcome [1]
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Mean Change In Hemoglobin From Baseline To Week 5
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline (Day 1), Week 5
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Secondary outcome [2]
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Participants Achieving A Hemoglobin Level =12.0 g/dL At Any Time From Baseline To Week 5
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Assessment method [2]
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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.
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Timepoint [2]
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Secondary outcome [3]
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Mean Change In TSAT From Baseline To Week 5
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline (Day 1), Week 5
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Secondary outcome [4]
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Mean Change In Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score From Baseline To Week 5
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline (Day 1), Week 5
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Secondary outcome [5]
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Time To Hemoglobin Increase Of =2.0 g/dL Or Hemoglobin Value Of =12.0 g/dL From Baseline
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Assessment method [5]
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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.
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Timepoint [5]
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From Baseline (Day 1) up to Week 5
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Eligibility
Key inclusion criteria
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 (TSAT) <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
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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(min)/1.73 square meter (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 nanogram/mL
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/08/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
25/06/2012
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Sample size
Target
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Accrual to date
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Final
605
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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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. - Adelaide
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Recruitment hospital [2]
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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. - Ballarat
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Recruitment hospital [3]
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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. - Concord
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Recruitment hospital [4]
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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. - Five Dock
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Recruitment hospital [5]
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Recruitment hospital [6]
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Recruitment hospital [7]
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Ballarat
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Recruitment postcode(s) [3]
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- Concord
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Recruitment postcode(s) [4]
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- Five Dock
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Recruitment postcode(s) [5]
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- Gosford
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Recruitment postcode(s) [6]
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- Kingswood
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Recruitment postcode(s) [7]
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- Parkville
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Recruitment outside Australia
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France
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La Tronche
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Mainz
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Germany
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Siegen
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Germany
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Cambridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AMAG Pharmaceuticals, Inc.
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Ethics approval
Ethics application status
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Summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01114204
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Trial related presentations / publications
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. 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.
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Public notes
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Contacts
Principal investigator
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01114204
Download to PDF