Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis

Phase 4

Completed

• Conditions: End Stage Renal Disease

• Registration Number: NCT00117104
• Lead Sponsor: Amgen

Brief Summary

The purpose of this study is to assess the Aranesp® dose administered intravenously (IV) once weekly to maintain hemoglobin (Hgb) levels in hemodialysis subjects who are either recombinant human erythropoietin (rHuEPO) naïve or subjects converted from rHuEPO therapy administered IV thrice weekly (TIW).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-04
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Subjects with end stage renal disease (ESRD) on hemodialysis

Exclusion Criteria

• Known hypersensitivity to Aranesp® (darbepoetin alfa) or any of its excipients - Participating in an investigational drug or device trial - Patient will not be available for follow-up assessment - Patient has any disorder that compromises the ability of the patient to give written informed consent and/or to comply with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Target hemoglobin (Hgb)

Secondary Outcome Measures

Name	Time	Method
Distribution of hemoglobin (Hgb) values by week