Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156949
Status:
COMPLETED
Last Update Posted:
2010-02-19
First Post:
2005-09-08
Brief Title:
EPO Deep Tank in Dialysis Subjects
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-Label Single-Arm Study to Assess the Safety of Epoetin Alfa Manufactured by a Deep Tank Technology in Subjects With Chronic Kidney Disease Receiving Dialysis
Status:
COMPLETED
Status Verified Date:
2010-02
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:
Subject incidence of adverse events
Detailed Description:
To determine whether Epoetin alfa manufactured by a roller bottle technology Epoetin alfa RB and Epoetin alfa manufactured by a deep tank process Epoetin alfa DT have comparable safety profiles when administered to patients with CKD receiving dialysis
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