Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00369733
Status:
COMPLETED
Last Update Posted:
2010-02-19
First Post:
2006-08-24
Brief Title:
STAAR-3 Clinical Study
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
DiseaseCase Management of Patients Receiving ARANESP Darbepoetin Alfa to Treat the Anemia of Chronic Renal Insufficiency CRI
Status:
COMPLETED
Status Verified Date:
2010-02
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 of CRI subjectswho are recombinant human erythropoetin rHuEPO-naïve or converting from rHuEPO therapy and 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 evaluate the extent to which implementation of case management contributes to achieving the desired clinical objectives
To assess the safety profile of Aranesp therapy in subjects with CRI
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 evaluate the extent to which implementation of case management contributes to achieving the desired clinical objectives
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