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Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients

This study has been completed.
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00255424
First received: November 17, 2005
Last updated: October 21, 2008
Last verified: October 2008

November 17, 2005
October 21, 2008
May 2004
Not Provided
The mean change in hemoglobin from baseline.
An increase in hemoglobin and ferritin at 3 to 5 weeks after the initiation of dosing.
Complete list of historical versions of study NCT00255424 on ClinicalTrials.gov Archive Site
Change in iron indices.
Clinical laboratory iron related measures including serum iron, ferritin, hemoglobin, reticulocyte count, iron saturation, percent hypochromic red cells and CHr.
Not Provided
Not Provided
 
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anemia
Drug: ferumoxytol or oral iron
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
304
August 2006
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00255424
62745-6
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
Not Provided
Not Provided
AMAG Pharmaceuticals, Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP