Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093977
Status:
COMPLETED
Last Update Posted:
2013-05-24
First Post:
2004-10-07
Brief Title:
Study to Assess Darbepoetin Alfa in Subjects With Chronic Kidney Disease
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open-label Single-Arm Study to Assess the Safety of Darbepoetin Alfa Manufactured by a Serum Free Bioreactor Technology in Subjects With Chronic Kidney Disease
Status:
COMPLETED
Status Verified Date:
2013-05
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:
The purpose of this study is to determine whether darbepoetin alfa manufactured by the current roller bottle technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile
Detailed Description:
None
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