A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease

NCT ID: NCT01052779

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-01
• Study Completion Date: 2012-04-19

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of intravenous (IV) ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in participants with chronic kidney disease (CKD).

Conditions

Iron Deficiency; Anemia; Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ferumoxytol

Participants received an IV injection of ferumoxytol (510 milligrams \[mg\], 17 milliliters \[mL\]) on Day 1 (Baseline). This was followed by a second injection of ferumoxytol (510 mg, 17 mL) 5±3 days later for a total cumulative dose of 1.02 grams (g).

Group Type: EXPERIMENTAL

Ferumoxytol

Intervention Type: DRUG

IV Ferumoxytol

Iron Sucrose

Participants received iron sucrose based on hemodialysis status. Participants on hemodialysis received either slow IV injection or IV drip infusion of 100 mg of iron sucrose on Day 1 (Baseline) and at the following 9 consecutive hemodialysis sessions for a total cumulative dose of 1.0 g.

Participants not on dialysis received either slow IV injection or IV drip infusion of 200 mg of iron sucrose on Day 1 (Baseline) and at 4 subsequent visits on nonconsecutive days over a 14-day period for a total cumulative dose of 1.0 g.

Group Type: ACTIVE_COMPARATOR

Iron Sucrose

Intervention Type: DRUG

IV Iron Sucrose

Interventions

Ferumoxytol

IV Ferumoxytol

Intervention Type: DRUG

Iron Sucrose

IV Iron Sucrose

Intervention Type: DRUG

Other Intervention Names

Feraheme; Venofer

Eligibility Criteria

Inclusion Criteria

1. Males and females ≥18 years of age

2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as nephropathy, nephritis)

3. Hemoglobin <11.0 g/deciliter (dL)

4. Transferrin saturation <30%

5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to screening and currently receiving dialysis 3 times per week

6. 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 the study

Exclusion Criteria

1. History of allergy to IV iron

2. Allergy to 2 or more classes of drugs

3. Female participants who are pregnant or intend to become pregnant, breastfeeding, within 3 months postpartum, or have a positive serum or urine pregnancy test

4. Hemoglobin ≤7.0 g/dL

5. Received another investigational agent within 4 weeks prior to screening, or planned receipt of an unspecified investigational agent during the study period

6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12 or folate deficiency)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AMAG Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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Tempe, Arizona, United States

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Chula Vista, California, United States

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Mountain View, California, United States

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Whittier, California, United States

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Augusta, Georgia, United States

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Meridian, Idaho, United States

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Evergreen Park, Illinois, United States

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Shreveport, Louisiana, United States

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Bethesda, Maryland, United States

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Springfield, Massachusetts, United States

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Flushing, New York, United States

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Rosedale, New York, United States

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Bethlehem, Pennsylvania, United States

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San Antonio, Texas, United States

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Antwerp, , Belgium

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Antwerp, , Belgium

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Vancouver, British Columbia, Canada

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Richmond Hill, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Berlin, , Germany

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Düsseldorf, , Germany

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Göttingen, , Germany

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Munich, , Germany

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Nuremberg, , Germany

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Passau, , Germany

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Bangalore, , India

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Nagpur, , India

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Pune, , India

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Katowice, , Poland

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Lodz, , Poland

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Opole, , Poland

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Radom, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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London, , United Kingdom

Countries

United States; Belgium; Canada; Germany; India; Poland; United Kingdom

References

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

PMID: 24639149 (View on PubMed)

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

PMID: 27462400 (View on PubMed)

Macdougall IC, Strauss WE, McLaughlin J, Li Z, Dellanna F, Hertel J. A randomized comparison of ferumoxytol and iron sucrose for treating iron deficiency anemia in patients with CKD. Clin J Am Soc Nephrol. 2014 Apr;9(4):705-12. doi: 10.2215/CJN.05320513. Epub 2014 Jan 23.

Reference Type: DERIVED

PMID: 24458078 (View on PubMed)

Other Identifiers

FER-CKD-201

Identifier Type: -

Identifier Source: org_study_id

2009-015630-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id