Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00368901
Status:
COMPLETED
Last Update Posted:
2010-03-05
First Post:
2006-08-24
Brief Title:
STAAR-2 Clinical Study
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Multicenter Study Using Once Every Other Week Subcutaneous Administration of Aranesp Darbepoetin Alfa and Iron Guided Algorithms to Treat Subjects With Anemia of Chronic Renal Insufficiency CRI
Status:
COMPLETED
Status Verified Date:
2010-03
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:
To assess the effect of Aranesp on the hemoglobin Hgb of CRI subjects who are recombinant human erythropoietin rHuEPO-naïve or converting from rHuEPO therapy
Detailed Description:
To assess the effect of Aranesp_ on the hemoglobin Hgb of CRI subjects who are recombinant human erythropoietin rHuEPO-naïve or converting from rHuEPO therapy To assess the association between subject self-reported health-related quality of life HRQoL as it relates to Hgb concentration and glomerular filtration rate GFR in subjects who were rHuEPO-naïve prior to study enrollment To characterize the health-related resource utilization of subjects with CRI To characterize the subject satisfaction with Aranesp_ compared to previous rHuEPO therapy To characterize iron treatment in subjects with CRI To assess the safety profile of Aranesp_ therapy in subjects with CRI
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