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NCT Number: NCT00255437

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

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ferumoxytol or oral iron

Drug

Primary outcomes

  1. The mean change in hemoglobin from baseline.

Secondary outcomes

  1. Change in iron indices.

Sponsors and collaborators

Lead sponsor

AMAG Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2004
Study completion
2006
First posted
Nov 21, 2005
Registry last updated
Jan 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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