Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111098
Status:
COMPLETED
Last Update Posted:
2008-08-08
First Post:
2005-05-17
Brief Title:
Treatment for Subjects With Chronic Kidney Disease CKD Not Receiving Dialysis
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Multicenter Single Arm Study Evaluating Once Monthly Darbepoetin Alfa Dosing In Subjects With Chronic Kidney Disease CKD Not Receiving Dialysis
Status:
COMPLETED
Status Verified Date:
2008-08
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 proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients not on dialysis Anemic patients who have achieved and maintained target hemoglobin Hb on every 2 weeks Q2W dosing of darbepoetin alfa will have the dosing interval extended to once monthly QM dosing Extending the dosing interval for darbepoetin alfa to QM represents a major potential benefit to both patients with CKD and their caregivers
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