NCT00368901

STAAR-2 Clinical Study

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 618 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Kidney Disease
• Chronic Renal Insufficiency
• Kidney Disease
• Pre-dialysis
• Pre-ESRD

Interventions

Type	Name	Description
DRUG	Darbepoetin alfa	Aranesp administered every other week SC titrated to not exceed Hb 12 g/dL

Timeline

• Start date: 2002-01-01
• Primary completion: 2004-03-01
• Completion: 2004-05-01
• First posted: 2006-08-29
• Last updated: 2010-03-05