Chronic Kidney Disease Clinical Trial
Official title:
A Multicenter Study Evaluating Once Every Other Week Subcutaneous Administration of Aranesp (Darbepoetin Alfa) in Subjects With Anemia of Chronic Renal Insufficiency (CRI)
To assess the effect of Aranesp on the hemoglobin of CRI subjects who are recombinant human erythropoetin (rHuEPO)-naïve or converting from rHuEPO therapy
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 assess the safety profile of Aranesp™ therapy in subjects with CRI. ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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