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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00117104
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : October 16, 2009
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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

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Study Type : Interventional  (Clinical Trial)
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Target hemoglobin (Hgb)

Secondary Outcome Measures :
  1. Distribution of hemoglobin (Hgb) values by week

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00117104

Sponsors and Collaborators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Global Development Leader, Amgen Inc. Identifier: NCT00117104     History of Changes
Other Study ID Numbers: 20030133
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by Amgen:
End Stage Renal Disease (ESRD)
Kidney Disease, Dialysis
Aranesp®, rHuEPO
Anemia, Hemoglobin
Dosing, Amgen

Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Darbepoetin alfa