Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156962
Status:
TERMINATED
Last Update Posted:
2008-07-21
First Post:
2005-09-08
Brief Title:
Epoetin Alfa EPO in Subjects With Chronic Kidney Disease CKD
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Open-Label Study to Assess the Safety of Epoetin Alfa Manufactured by Deep Tank Technology and Epoetin Alfa Manufactured by Roller Bottle Technology in Subjects With Chronic Kidney Disease Not on Dialysis
Status:
TERMINATED
Status Verified Date:
2008-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Regulatory decision not to proceed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to look at 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 a comparable safety profile when administered to patients with CKD not on 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NOT APPLILCABLE | None | None | None |