Clinical trial NCT00255424: Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anemia
Lead sponsor: AMAG Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2005-11-21
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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 with chronic kidney disease who are not on dialysis.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The mean change in hemoglobin from baseline.
Secondary outcomes:
measure: Change in iron indices.
Other outcomes:
Locations:
city: Encino
country: United States
state: California
city: Riverside
country: United States
state: California
city: Tarzana
country: United States
state: California
city: Ocala
country: United States
state: Florida
city: Shreveport
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Springfield
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Flushing
country: United States
state: New York
city: Orchard Park
country: United States
state: New York
city: Columbus
country: United States
state: Ohio
city: Hershey
country: United States
state: Pennsylvania
city: Lancaster
country: United States
state: Pennsylvania
city: Chattanooga
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Fairfax
country: United States
state: Virginia
city: Bluefield
country: United States
state: West Virginia
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: Spinowitz BS, Kausz AT, Baptista J, Noble SD, Sothinathan R, Bernardo MV, Brenner L, Pereira BJ. Ferumoxytol for treating iron deficiency anemia in CKD. J Am Soc Nephrol. 2008 Aug;19(8):1599-605. doi: 10.1681/ASN.2007101156. Epub 2008 Jun 4.
citation: 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. doi: 10.5414/cn107397.