Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease 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 Chronic Kidney Disease Patients Not on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255437
• Other study ID #: 62745-7
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2005
• Last updated: January 7, 2015
• Start date: June 2004
• Est. completion date: November 2006

Study information

• Verified date: October 2007
• Source: AMAG Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 with chronic kidney disease who are not on dialysis.

Description:

This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients = 18 years.

• Have chronic kidney disease per K/DOQI guidelines.

• No change in EPO status during study.

• Baseline hemoglobin of = 11.0 g/dl.

Exclusion Criteria:

• Women who are pregnant or lactating.

• 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 major surgery during the study.

• Patients whose EPO status changes while on study.

• Patients with active infections.

• Recent blood transfusions.

• Patients with any known allergies to iron products.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Kidney Diseases
• Renal Insufficiency, Chronic

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)

Fishbane S, Bolton WK, Winkelmayer WC, Strauss W, Li Z, Pereira BJ. Factors affecting response and tolerability to ferumoxytol in nondialysis chronic kidney disease patients. Clin Nephrol. 2012 Sep;78(3):181-8. — View Citation

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

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