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Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00233597
Recruitment Status : Completed
First Posted : October 6, 2005
Last Update Posted : April 4, 2022
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2005
First Posted Date  ICMJE October 6, 2005
Last Update Posted Date April 4, 2022
Study Start Date  ICMJE August 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2006)
The mean change in hemoglobin from baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
An increase in hemoglobin and ferritin at 3 to 5 weeks after the initiation of dosing.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2006)
Change in iron indices.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2005)
Clinical laboratory iron related measures including serum iron, ferritin, hemoglobin, reticulocyte count, iron saturation, percent hypochromic red cells and CHr.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis Patients
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anemia
Intervention  ICMJE Drug: ferumoxytol or oral iron
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: May 25, 2006)
230
Original Enrollment  ICMJE
 (submitted: October 4, 2005)
350
Actual Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00233597
Other Study ID Numbers  ICMJE 62745-5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE AMAG Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account AMAG Pharmaceuticals, Inc.
Verification Date April 2022

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