Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00096915
Status:
COMPLETED
Last Update Posted:
2009-05-22
First Post:
2004-11-17
Brief Title:
Study Evaluating Darbepoetin Alfa in Subjects With Chronic Kidney Disease CKD 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 Receiving Dialysis
Status:
COMPLETED
Status Verified Date:
2009-05
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 proposed study is designed to test a novel dosing paradigm that would facilitate the treatment of anemia in CKD patients on dialysis Anemic patients on hemo and peritoneal dialysis who have achieved and maintained target hemoglobin Hb on every other week Q2W dosing of darbepoetin alfa will have the dosing interval extended to once monthly QM dosing
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