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Aranesp® Monthly Preference Study - 2

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ClinicalTrials.gov Identifier: NCT00117078
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : September 30, 2008
Sponsor:
Information provided by:
Amgen

Brief Summary:
The purpose of this study was to evaluate subject preference for Aranesp® administered once monthly (i.e., every 4 weeks (Q4W)) or Procrit® administered once weekly (QW).

Condition or disease Intervention/treatment Phase
Kidney Disease Drug: Aranesp® Phase 4

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aranesp® Monthly Preference Study - 2

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Subject preference

Secondary Outcome Measures :
  1. Subject productivity and subject selection of Aranesp® or Procrit® therapy in the parallel arm portion and at study conclusion.


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
Criteria
Inclusion Criteria: - Subjects must have signed written informed consent - Be on Procrit® QW or Q2W for a minimum of 8 weeks - Must currently be on a stable dose of Procrit® (defined as less than 25% change in Procrit® dose over the 4 week period immediately prior to enrollment, with no missed doses) - Have Hgb 10-12 g/dL for at least 4 weeks prior to study start - Have 15 less than GFR less than 89 mL/min/1.73 m2 Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Self-injecting at home with Procrit® - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy

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 ClinicalTrials.gov identifier (NCT number): NCT00117078


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117078     History of Changes
Other Study ID Numbers: 20020380
First Posted: July 4, 2005    Key Record Dates
Last Update Posted: September 30, 2008
Last Verified: September 2008

Keywords provided by Amgen:
Kidney disease, Renal, CKD (Chronic Kidney Disease)
CRI (Chronic Renal Insufficiency), Pre-dialysis, Amgen
Aranesp®, Darbepoetin alfa, QW dosing
Q2W dosing, Q4W dosing
Patient preference, Subject preference

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Darbepoetin alfa
Hematinics