Anemia
Conditions
Keywords
anemia
Brief summary
This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.
Detailed description
This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.
Interventions
DRUGferumoxytol or placebo
Sponsors
AMAG Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients \> 18 years. * Have chronic kidney disease per K/DOQI guidelines. * Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl
Exclusion criteria
* Women who are pregnant or lactating. * Received another investigational drug or device within 30 days. * Recent parenteral or oral iron therapy. * Patients that have other causes of anemia. * Major surgery within 30 days or anticipated or planned surgery during the study. * Patients with active infections. * Recent blood transfusions. * Patients with known allergies to iron products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety evaluated by physical examinations, vital signs, laboratory tests and patient monitoring and evaluation. | — |
Countries
United States
Outcome results
None listed