Expired Study
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North Brunswick, New Jersey 08902


Purpose:

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.


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


NCT ID:

NCT01148745


Primary Contact:

Principal Investigator
Toros Kapoian, MD
DCI North Brunswick


Backup Contact:

N/A


Location Contact:

North Brunswick, New Jersey 08902
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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