Iron Indices and Intravenous Ferumoxytol: Time to Steady State

Dialysis Clinic, Inc.

Status and phase

Completed

Phase 4

Conditions

Iron Deficiency Anemia

Treatments

Drug: ferumoxytol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01148745

DCI-0001

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

All

Volunteers

No Healthy Volunteers

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