Anemia
Conditions
Brief summary
The study will evaluate the safety and efficacy of a new intravenously administered iron drug to treat anemia in patients with chronic kidney disease who are not on dialysis.
Detailed description
This study will evaluate the efficacy and safety of intravenous (IV) ferumoxytol as compared to oral iron in the treatment of anemia in non-dialysis dependent CKD patients. Patients are randomized to receive either two doses of 510 mg of ferumoxytol within one week or 200 mg oral elemental iron daily for three weeks.
Interventions
Sponsors
AMAG Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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. * No change in EPO status during study. * Baseline hemoglobin of ≤ 11.0 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 with active GI bleeding or acute bleeding within 4 weeks. * Patients that have other causes of anemia. * Major surgery within 30 days or anticipated or planned major surgery during the study. * Patients whose EPO status changes while on study. * Patients with active infections. * Recent blood transfusions. * Patients with any known allergies to iron products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in hemoglobin from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in iron indices. | — |
Countries
United States
Outcome results
None listed