Trials / Completed
CompletedNCT00255424
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
A Phase III Study of the Safety and Efficacy of Ferumoxytol (Compared With Oral Iron) as an Iron Replacement Therapy in Chronic Kidney Disease Patients Not on Dialysis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 304 (planned)
- Sponsor
- AMAG Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ferumoxytol or oral iron |
Timeline
- Start date
- 2004-05-01
- Completion
- 2006-08-01
- First posted
- 2005-11-21
- Last updated
- 2015-01-09
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00255424. Inclusion in this directory is not an endorsement.