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

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT00117104

Collaborator

(none)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
End Stage Renal Disease	Drug: Aranesp®	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis

Outcome Measures

Primary Outcome Measures

Target hemoglobin (Hgb) []

Secondary Outcome Measures

Distribution of hemoglobin (Hgb) values by week []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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