Iron Indices and Intravenous Ferumoxytol: Time to Steady State

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the time point of transferrin saturation (TSAT) and ferritin stabilization after a thirteen-treatment period following a ferumoxytol load, as well as to determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dialysis Clinic, Inc.
• Treatments: Ferrosoferric Oxide

Criteria

Inclusion Criteria:

• Chronic hemodialysis subjects who have received dialysis treatment for more than 90 days

• TSAT less than or equal to 25 percent

• Serum ferritin less than or equal to 200 nanograms/milliliter (ng/mL)

• (Female) Subjects are willing to use reliable contraception, or have undergone menopause (chemical or surgical)

• Subjects who are able to read and write in English

• Subjects who have signed consent

Exclusion Criteria:

• Subjects who have been enrolled in a clinical trial within the past 30 days

• Subjects who have received IV iron within 4 weeks of the start of the study

• Serum ferritin greater than or equal to 1200 ng/dL

• Hemoglobin (Hb) less than 10 grams/deciliter (g/dL), or greater than 13.5 g/dL

• Evidence of iron overload

• Known hypersensitivity to ferumoxytol or any of its components

• Anemia caused by conditions other than iron deficiency

• Subjects with elective surgeries scheduled within the next 3 months

• Subjects with elective magnetic resonance procedure scheduled during the study period

• Subjects who have been hospitalized within the past 30 days (excluding vascular access care)

• Subjects who have received a blood transfusion in the past 30 days

• Subjects who are transfusion dependent

• (Female) Subjects who are pregnant or nursing

• Subjects with known inflammatory conditions which may affect serum ferritin

• Subjects who are considered to be clinically unstable at the discretion of Principal Investigator (P.I.)

• Subjects who have a clinically unstable blood pressure (BP) of systolic greater than 180 millimeters of mercury (mmHg) and/or diastolic greater than 100 mmHg (sitting, pre-dialysis)

• Subjects with life expectancy less than 6 months

• Subjects who refuse to sign consent