Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236977
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2005-10-07
Brief Title:
Comparison of Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
Comparison of the Safety and Efficacy of Intravenous Iron Versus Oral Iron in Chronic Renal Failure Subjects With Anemia
Status:
COMPLETED
Status Verified Date:
2020-09
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:
To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent chronic renal failure in patients receiving or not receiving erythropoietin
Detailed Description:
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent chronic renal failure patients receiving or not receiving erythropoietin After an extensive enrollment period patients were randomized to receive oral iron ferrous sulfate 325mg three times daily TID for 56 days or IV iron sucrose total 1000mg 500mg X 2 OR 200mg X 5 within two weeks Erythropoietin schedule was to remain unchanged during the 56 day study
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