Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

Anemia Clinical Trial

Official title:

A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00233597
• Other study ID #: 62745-5
• Status: Completed
• Phase: Phase 3
• Start date: August 2004
• Est. completion date: March 2007

Study information

• Verified date: April 2022
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients on hemodialysis.

Description:

This study will evaluate the efficacy and safety of intravenous (IV) iron (ferumoxytol) as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin. Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions or 200 mg oral elemental iron daily for three weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients =18 years.

• Chronic hemodialysis.

• Stable supplemental EPO therapy.

• Baseline hemoglobin of = 11.5 g/dl.

Exclusion Criteria:

• Women who are pregnant or who are breast feeding.

• Received another investigational drug or device within 30 days.

• Recent parenteral or oral iron therapy.

• Patients with active GI bleeding or acute bleeding within 4 weeks. Patients that have other causes of anemia.

• Major surgery within 30 days or anticipated or planned surgery during the study.

• Patients with active infections.

• Recent blood transfusions.

• Patients with known allergies to iron products.

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• ferumoxytol or oral iron

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AMAG Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (2)

Landry R, Jacobs PM, Davis R, Shenouda M, Bolton WK. Pharmacokinetic study of ferumoxytol: a new iron replacement therapy in normal subjects and hemodialysis patients. Am J Nephrol. 2005 Jul-Aug;25(4):400-10. Epub 2005 Jul 28. — View Citation

Provenzano R, Schiller B, Rao M, Coyne D, Brenner L, Pereira BJ. Ferumoxytol as an intravenous iron replacement therapy in hemodialysis patients. Clin J Am Soc Nephrol. 2009 Feb;4(2):386-93. doi: 10.2215/CJN.02840608. Epub 2009 Jan 28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean change in hemoglobin from baseline.
Secondary	Change in iron indices.

External Links

•   National Kidney Foundation