A Trial Comparing Ferumoxytol With Iron Sucrose for the Treatment of Iron Deficiency Anemia
NCT ID: NCT01114204
Last Updated: 2022-04-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
605 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-08-10
Study Completion Date
2012-06-25
Brief Summary
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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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Detailed Description
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Conditions
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Iron Deficiency Anemia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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).
Group Type
EXPERIMENTAL
Ferumoxytol
Intervention Type
DRUG
IV Ferumoxytol
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.
Group Type
ACTIVE_COMPARATOR
Iron Sucrose
Intervention Type
DRUG
IV Iron Sucrose
Interventions
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Ferumoxytol
IV Ferumoxytol
Intervention Type
DRUG
Iron Sucrose
IV Iron Sucrose
Intervention Type
DRUG
Other Intervention Names
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Feraheme
Venofer
Eligibility Criteria
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Inclusion Criteria
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
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
Exclusion Criteria
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
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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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AMAG Pharmaceuticals, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Cherkasy, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Cambridge, , United Kingdom
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London, , United Kingdom
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Countries
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Australia
France
Germany
Hungary
Italy
Latvia
Lithuania
Poland
Romania
South Africa
South Korea
Spain
Ukraine
United Kingdom
References
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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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Other Identifiers
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AMAG-FER-IDA-302
Identifier Type: -
Identifier Source: org_study_id
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COMPLETED
PHASE3
Bioequivalence Study of Iron Sucrose Injection in Healthy Subjects
NCT06622148
COMPLETED
PHASE1
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents
NCT00224042
COMPLETED
PHASE4
Effect of Two Iron Preparations on Protein in the Urine
NCT00354692
COMPLETED
PHASE4
Efficacy of Ferric Carboxymaltose Versus Iron Sucrose in Non-dialysis Dependent Chronic Kidney Disease Patients
NCT06994065
RECRUITING
NA
Intravenous (IV) Iron vs. No Iron as the Treatment of Anemia in Cancer Patients Undergoing Chemotherapy and Erythropoietin Therapy
NCT00236951
COMPLETED
PHASE3
Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients
NCT00224055
COMPLETED
PHASE4
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
NCT01264679
TERMINATED
PHASE3
2 Doses of Ferrlecit Versus Oral Iron to Treat Iron-deficiency Anemia in Peritoneal Dialysis Patients.
NCT00223977
COMPLETED
PHASE2/PHASE3
Iron Isomaltoside for the Treatment of Anemia in Peritoneal Dialysis Patients
NCT06830941
NOT_YET_RECRUITING
PHASE4
Bioequivalence Study of Ferric Carboxymaltose Injection in Participants With Iron Deficiency Anaemia
NCT06080555
COMPLETED
PHASE1
A Study Comparing Two Ferric Carboxymaltose Formulations in Patients With Iron Deficiency Anemia
NCT03399084
COMPLETED
PHASE1
Trial Comparing the Safety of Two Different Intravenous Iron Formulations
NCT00593619
SUSPENDED
PHASE4
Study With Oral Ferric Maltol for the Treatment of Iron Deficiency Anemia in Subjects With Chronic Kidney Disease
NCT02968368
COMPLETED
PHASE3
Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
NCT00223964
COMPLETED
PHASE4
Intravenous Iron in Patients With Anemia of Chronic Kidney Disease
NCT00204256
UNKNOWN
PHASE4
Intravenous Treatment of Anemia in Pregnancy
NCT03317210
COMPLETED
PHASE4
Treatment Response of Injectafer vs Oral Iron to Baseline Hepcidin Levels in Patients With Iron Deficiency Anemia (IDA) Secondary to Inflammatory Bowel Disease (IBD) or Gastric Bypass
NCT02086968
COMPLETED
PHASE4
Iron Sucrose in Stage 3/4 Kidney Disease
NCT00202345
COMPLETED
PHASE3
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
NCT00236964
COMPLETED
PHASE3
A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia
NCT04350606
COMPLETED
PHASE3
A Single Ascending Study of IOP Injection in Patients With Iron Deficient Anemia
NCT03485053
TERMINATED
PHASE2