Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00223938
Status:
TERMINATED
Last Update Posted:
2021-06-24
First Post:
2005-09-13
Brief Title:
Study of the Efficacy and Safety of Ferrlecit in the Maintenance Dosing in Hemodialysis Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Multi-center Open-label Randomized Parallel Group Study of the Efficacy and Safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin
Status:
TERMINATED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated because of significant enrollment challenges
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 4 clinical investigation of the efficacy and safety of Ferrlecit in the maintenance of iron stores and serum hemoglobin concentration in hemodialysis patients receiving Erythropoietin
Detailed Description:
A Multi-Center Open-Label Parallel Group Study of the efficacy and safety of Ferrlecit in the Maintenance of Iron Stores and Serum Hemoglobin Concentration in Hemodialysis Patients Receiving Erythropoietin Patients with normal iron indices receive one of two doses of Ferrlecit administered weekly throughout the treatment period Efficacy was assesses at designated timepoints throughout the study and after the last Ferrlecit dose
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