STAAR-3 Clinical Study
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.
Chronic Kidney Disease
Chronic Renal Insufficiency
Drug: Darbepoetin alfa
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)|
- Mean hemoglobin during the evaluation period. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Change in hemoglobin throughout the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Health-related resource utilization, measured every 4 weeks, throughout the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
- Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Iron requirement (dose, frequency, and route) of subjects during the study [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2002|
|Study Completion Date:||May 2004|
|Primary Completion Date:||March 2004 (Final data collection date for primary outcome measure)|
Experimental: Single arm
Aranesp adminsitered every other week for 52 weeks
Drug: Darbepoetin alfa
Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL
Other Name: Aranesp
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.