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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01114204




Registration number
NCT01114204
Ethics application status
Date submitted
29/04/2010
Date registered
3/05/2010
Date last updated
11/06/2018

Titles & IDs
Public title
A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Scientific title
A Phase III, Randomized, Open-label, Active-Controlled, Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
Secondary ID [1] 0 0
AMAG-FER-IDA-302
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Iron Deficiency Anemia 0 0
Condition category
Condition code
Blood 0 0 0 0
Anaemia
Diet and Nutrition 0 0 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 1) through Week 5
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline (Day 1), Week 5
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline (Day 1) through Week 5
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline (Day 1), Week 5
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline (Day 1), Week 5
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
From Baseline (Day 1) up to Week 5

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

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
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
Recruitment hospital [2] 0 0
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
Recruitment hospital [3] 0 0
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
Recruitment hospital [4] 0 0
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
Recruitment hospital [5] 0 0
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. - Gosford
Recruitment hospital [6] 0 0
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. - Kingswood
Recruitment hospital [7] 0 0
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. - Parkville
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Ballarat
Recruitment postcode(s) [3] 0 0
- Concord
Recruitment postcode(s) [4] 0 0
- Five Dock
Recruitment postcode(s) [5] 0 0
- Gosford
Recruitment postcode(s) [6] 0 0
- Kingswood
Recruitment postcode(s) [7] 0 0
- Parkville
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
La Tronche
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Germany
State/province [3] 0 0
Frankfurt
Country [4] 0 0
Germany
State/province [4] 0 0
Mainz
Country [5] 0 0
Germany
State/province [5] 0 0
Siegen
Country [6] 0 0
Germany
State/province [6] 0 0
Wilhelmshaven
Country [7] 0 0
Hungary
State/province [7] 0 0
Békéscsaba
Country [8] 0 0
Hungary
State/province [8] 0 0
Gyula
Country [9] 0 0
Hungary
State/province [9] 0 0
Komárom
Country [10] 0 0
Hungary
State/province [10] 0 0
Miskolc
Country [11] 0 0
Hungary
State/province [11] 0 0
Szekszárd
Country [12] 0 0
Hungary
State/province [12] 0 0
Szolnok
Country [13] 0 0
Hungary
State/province [13] 0 0
Vác
Country [14] 0 0
Hungary
State/province [14] 0 0
Zalaegerszeg
Country [15] 0 0
Italy
State/province [15] 0 0
Padova
Country [16] 0 0
Italy
State/province [16] 0 0
Rozzano
Country [17] 0 0
Korea, Republic of
State/province [17] 0 0
Cheonan
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Daegu
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Incheon
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Seoul
Country [21] 0 0
Korea, Republic of
State/province [21] 0 0
Suwon
Country [22] 0 0
Latvia
State/province [22] 0 0
Daugavpils
Country [23] 0 0
Latvia
State/province [23] 0 0
Riga
Country [24] 0 0
Latvia
State/province [24] 0 0
Ventspils
Country [25] 0 0
Lithuania
State/province [25] 0 0
Kaunas
Country [26] 0 0
Lithuania
State/province [26] 0 0
Klaipeda
Country [27] 0 0
Lithuania
State/province [27] 0 0
Vilnius
Country [28] 0 0
Lithuania
State/province [28] 0 0
Šiauliai
Country [29] 0 0
Poland
State/province [29] 0 0
Bialystok
Country [30] 0 0
Poland
State/province [30] 0 0
Katowice
Country [31] 0 0
Poland
State/province [31] 0 0
Kraków
Country [32] 0 0
Poland
State/province [32] 0 0
Sopot
Country [33] 0 0
Poland
State/province [33] 0 0
Warszawa
Country [34] 0 0
Poland
State/province [34] 0 0
Wroclaw
Country [35] 0 0
Poland
State/province [35] 0 0
Zgierz
Country [36] 0 0
Poland
State/province [36] 0 0
Leczyca
Country [37] 0 0
Romania
State/province [37] 0 0
Brasov
Country [38] 0 0
Romania
State/province [38] 0 0
Bucharest
Country [39] 0 0
Romania
State/province [39] 0 0
Iasi
Country [40] 0 0
Romania
State/province [40] 0 0
Suceava
Country [41] 0 0
Romania
State/province [41] 0 0
Timisoara
Country [42] 0 0
Romania
State/province [42] 0 0
Târgu-Mures
Country [43] 0 0
South Africa
State/province [43] 0 0
Cape Town
Country [44] 0 0
South Africa
State/province [44] 0 0
Durban
Country [45] 0 0
South Africa
State/province [45] 0 0
Roodepoort
Country [46] 0 0
South Africa
State/province [46] 0 0
Stellenbosch
Country [47] 0 0
Spain
State/province [47] 0 0
Barcelona
Country [48] 0 0
Spain
State/province [48] 0 0
Manresa
Country [49] 0 0
Spain
State/province [49] 0 0
Santa Cruz De Tenerife
Country [50] 0 0
Spain
State/province [50] 0 0
Sevilla
Country [51] 0 0
Ukraine
State/province [51] 0 0
Cherkasy
Country [52] 0 0
Ukraine
State/province [52] 0 0
Chernivtsi
Country [53] 0 0
Ukraine
State/province [53] 0 0
Donetsk
Country [54] 0 0
Ukraine
State/province [54] 0 0
Ivano-Frankivsk
Country [55] 0 0
Ukraine
State/province [55] 0 0
Kyiv
Country [56] 0 0
Ukraine
State/province [56] 0 0
Odessa
Country [57] 0 0
Ukraine
State/province [57] 0 0
Simferopol
Country [58] 0 0
Ukraine
State/province [58] 0 0
Vinnytsya
Country [59] 0 0
Ukraine
State/province [59] 0 0
Zaporizhzhya
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Cambridge
Country [61] 0 0
United Kingdom
State/province [61] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AMAG Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

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).
Trial website
https://clinicaltrials.gov/show/NCT01114204
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.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications