Clinical trial NCT00233597: Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Keywords: anemia
iron
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-06
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mean change in hemoglobin from baseline.
Secondary outcomes:
measure: Change in iron indices.
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Los Angeles
country: United States
state: California
city: Mountain View
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Hudson
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Augusta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Gurnee
country: United States
state: Illinois
city: Hines
country: United States
state: Illinois
city: Baton Rouge
country: United States
state: Louisiana
city: Bethesda
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Columbus
country: United States
state: Mississippi
city: Jackson
country: United States
state: Mississippi
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Brooklyn
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Brooklyn
country: United States
state: New York
city: Flushing
country: United States
state: New York
city: Mineola
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Springfield Gardens
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Lewistown
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Sumter
country: United States
state: South Carolina
city: Knoxville
country: United States
state: Tennessee
city: Memphis
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Alexandria
country: United States
state: Virginia
city: Chesapeake
country: United States
state: Virginia
city: Fairfax
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
city: Spokane
country: United States
state: Washington
city: Appleton
country: United States
state: Wisconsin
Study officials:
References:
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. doi: 10.1159/000087212. Epub 2005 Jul 28.
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.