Official Title
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Phase
Phase 4Lead Sponsor
Dialysis Clinic, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
Iron Deficiency AnemiaIntervention/Treatment
ferumoxytol ...Study Participants
15The 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.
510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)
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
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TSAT,ferritin,and TIBC measured before start of dialysis on dosing days, and on next 13 HD treatments. Continuous variables were summarized using median. Paired continuous data (e.g., TSAT, serum ferritin) were compared using the Wilcoxon signed rank test. Analyses evaluating stabilization of post drug iron indices was determined by comparing consecutive values at consecutive dialysis sessions and when there was no longer a difference between 2 consecutive time points, levels were considered stabilized. P-values <0.05 were considered statistically significant.
Transferrin saturation (TSAT) measured as a percentage, is a medical laborastory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100
Serum ferritin values were measured at all visits
