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

Amgen

Status and phase: Completed; Phase 4

Conditions: End Stage Renal Disease

Treatments: Drug: Aranesp®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00117104

20030133

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)