Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255424
Status:
COMPLETED
Last Update Posted:
2015-01-09
First Post:
2005-11-17
Brief Title:
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease Patients
Sponsor:
AMAG Pharmaceuticals Inc
Organization:
AMAG Pharmaceuticals Inc
Study Overview
Official Title:
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
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None