Back to resultsEvaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
Primary Purpose
End Stage Renal Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Aranesp®
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Target hemoglobin (Hgb)
Secondary Outcome Measures
Distribution of hemoglobin (Hgb) values by week
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00117104
Brief Title
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
Official Title
A Multicenter Study Evaluating Once Weekly Intravenous Administration of Aranesp® in Subjects With End Stage Renal Disease on Chronic Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Amgen
4. Oversight
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
End Stage Renal Disease (ESRD), Kidney Disease, Dialysis, Aranesp®, rHuEPO, Anemia, Hemoglobin, Dosing, Amgen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Aranesp®
Primary Outcome Measure Information:
Title
Target hemoglobin (Hgb)
Secondary Outcome Measure Information:
Title
Distribution of hemoglobin (Hgb) values by week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
Evaluating Aranesp® in Subjects With End Stage Renal Disease onChronic Hemodialysis
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