Clinical trial NCT01148745: Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Official title: Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Iron Deficiency Anemia
Lead sponsor: Dialysis Clinic, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-22
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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 determine the point at which serum ferritin and TSAT concentrations can be checked in iron deficiency anemia (IDA) hemodialysis patients.


Eligibility 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

Primary outcomes:
measure: Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize
timeFrame: pre-dosing/baseline, and 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 (visit 14) days after drug administration
Secondary outcomes:
measure: Transferrin Saturation (TSAT)
timeFrame: 7 (visit 5), 14 (visit 8), 21 (visit 11), and 28 (visit14) days.
measure: Serum Ferritin
timeFrame: 7 (visit 5), 14 (visit 8), 21 (visit 11) and 28 days (visit 14)
Other outcomes:
Locations:
city: North Brunswick
country: United States
facility: Dialysis Clinic, Inc.
state: New Jersey
Study officials:
affiliation: DCI North Brunswick
name: Toros Kapoian, MD
role: PRINCIPAL_INVESTIGATOR
References: