A Crossover Safety Study of Ferumoxytol Versus Placebo

This study has been completed.
Sponsor:
Information provided by:
AMAG Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00255450
First received: November 17, 2005
Last updated: November 10, 2008
Last verified: October 2007
  Purpose

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


Condition Intervention Phase
Anemia
Drug: ferumoxytol or placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double Blind, Placebo Controlled, Crossover Design, Multicenter Study of Intravenous Ferumoxytol Compared With Placebo

Resource links provided by NLM:


Further study details as provided by AMAG Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation.

Estimated Enrollment: 750
Study Start Date: January 2005
Study Completion Date: August 2006
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255450

  Show 41 Study Locations
Sponsors and Collaborators
AMAG Pharmaceuticals, Inc.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00255450     History of Changes
Other Study ID Numbers: 62745-8
Study First Received: November 17, 2005
Last Updated: November 10, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by AMAG Pharmaceuticals, Inc.:
anemia

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Ferumoxytol
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014