Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Completed · Phase 4

Conditions studied: Iron Deficiency Anemia

In brief

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.

Key facts

Study ID

NCT01148745

Run by

Dialysis Clinic, Inc.

People needed

15

Starts

2010-03-01

Expected to finish

2010-05-01

Last updated by the study team

2012-03-30

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dialysis Clinic, Inc. — North Brunswick, New Jersey, United States

Full record on ClinicalTrials.gov

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