NCT00369733

STAAR-3 Clinical Study

Disease/Case Management of Patients Receiving ARANESP™ (Darbepoetin Alfa) to Treat the Anemia of Chronic Renal Insufficiency (CRI)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 443 (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 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Darbepoetin alfa	Darbepoetin alfa adminstered SC every other week to acheive a Hb not to exceed 12 g/dL

Timeline

• Start date: 2002-05-01
• Primary completion: 2004-03-01
• Completion: 2004-05-01
• First posted: 2006-08-29
• Last updated: 2010-02-19