STAAR-3 Clinical Study
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|ClinicalTrials.gov Identifier: NCT00369733|
Recruitment Status : Completed
First Posted : August 29, 2006
Last Update Posted : February 19, 2010
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Chronic Renal Insufficiency Kidney Disease Pre-dialysis Pre-ESRD||Drug: Darbepoetin alfa||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||443 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)|
|Study Start Date :||May 2002|
|Actual Primary Completion Date :||March 2004|
|Actual Study Completion Date :||May 2004|
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
- Mean hemoglobin during the evaluation period. [ Time Frame: 52 weeks ]
- Change in hemoglobin throughout the study [ Time Frame: 52 weeks ]
- HRQoL scores of rHuEPO-naïve subjects measured at baseline, week 12, week 24, and end of study [ Time Frame: 52 weeks ]
- Health-related resource utilization, measured every 4 weeks, throughout the study [ Time Frame: 52 weeks ]
- Patient satisfaction scores of subjects previously on rHuEPO therapy, measured at baseline and week 12 [ Time Frame: 12 weeks ]
- Iron requirement (dose, frequency, and route) of subjects during the study [ Time Frame: 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00369733