Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00233597
Status:
COMPLETED
Last Update Posted:
2022-04-04
First Post:
2005-10-04
Brief Title:
Ferumoxytol Versus Oral Iron in the Treatment of Anemia in Hemodialysis 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 Hemodialysis Patients Who Are Receiving Supplemental EPO Therapy
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 on hemodialysis
Detailed Description:
This study will evaluate the efficacy and safety of intravenous IV iron ferumoxytol as compared to oral iron in the treatment of anemia in hemodialysis patients receiving erythropoietin Patients are randomized to receive either two doses of 510 mg of intravenous ferumoxytol in sequential dialysis sessions 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