Phase 4
N=15
Iron Indices and Intravenous Ferumoxytol: Time to Steady State
Iron Deficiency Anemia
Bottom Line
View on ClinicalTrials.gov: NCT01148745 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcome: Primary: Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize — 2 weeks
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- ferumoxytol (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dialysis Clinic, Inc.
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Weeks Until Transferrin Saturation (TSAT) and Ferritin Stabilize |
2 | — |
| SECONDARY Transferrin Saturation (TSAT) |
27.6; 26.7; 23.9; 26.7 | — |
| SECONDARY Serum Ferritin |
912; 713; 679; 670 | — |
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
Data sourced from ClinicalTrials.gov (NCT01148745). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.