Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236964
Status:
COMPLETED
Last Update Posted:
2018-01-24
First Post:
2005-10-07
Brief Title:
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Sponsor:
American Regent Inc
Organization:
American Regent Inc
Study Overview
Official Title:
Comparison of Oral Iron With IV Iron in Patients With Anemia of Chronic Renal Failure Not on Dialysis
Status:
COMPLETED
Status Verified Date:
2018-01
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 purpose of the study was to compare the efficacy of oral iron ferrous sulfate plus erythropoietin to Iron Sucrose plus erythropoietin for managing anemia patients with chronic renal failure who are not receiving dialysis
Detailed Description:
Randomized open-label multicenter active-controlled study of anemic patients with Chronic Renal Failure who are not yet receiving dialysis The duration of the study was five months After screening procedures including multiple hemoglobin values patients were randomly assigned to either IV Iron Sucrose 200mg X 5 or oral iron sulfate 325mg TIDfor 29 days Safety assessments included the recording of all adverse events physical examinations vital signs electrocardiograms and clinical laboratory tests Efficacy parameters included hematologic parameters
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