Status:
COMPLETED
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Lead Sponsor:
Dialysis Clinic, Inc.
Conditions:
Iron Deficiency Anemia
Eligibility:
All Genders
Phase:
PHASE4
Brief 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 determ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01148745
Start Date
March 1 2010
End Date
May 1 2010
Last Update
March 30 2012
Active Locations (1)
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1
Dialysis Clinic, Inc.
North Brunswick, New Jersey, United States, 08902