A Crossover Safety Study of Ferumoxytol Versus Placebo

Anemia Clinical Trial

Official title:

A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00255450
• Other study ID #: 62745-8
• Status: Completed
• Phase: Phase 3
• First received: November 17, 2005
• Last updated: November 10, 2008
• Start date: January 2005
• Est. completion date: August 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

This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.

Description:

This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: August 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.

• Baseline hemoglobin of > 9.0 and < 12.5 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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia

Intervention

Drug:
• ferumoxytol or placebo

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

Singh A, Patel T, Hertel J, Bernardo M, Kausz A, Brenner L. Safety of ferumoxytol in patients with anemia and CKD. Am J Kidney Dis. 2008 Nov;52(5):907-15. doi: 10.1053/j.ajkd.2008.08.001. Epub 2008 Sep 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.

External Links

•   National Kidney Foundation