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Study to Evaluate Effectiveness of Aranesp®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117130
First Posted: July 4, 2005
Last Update Posted: January 21, 2011
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.
Information provided by:
Amgen
  Purpose
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 Intervention Phase
Kidney Disease Drug: Aranesp® Phase 4

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Subject preference

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 12 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 - Have serum vitamin B12 and folate levels above the lower limits of normal - Transferrin saturation greater than 20% Exclusion Criteria: - Currently receiving investigational erythropoietic agents - Expected to initiate renal replacement therapy (dialysis or transplantation) within 1 year of study start - Have less than 1 year life expectancy
  Contacts and Locations
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): NCT00117130


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117130     History of Changes
Other Study ID Numbers: 20020147
First Submitted: June 30, 2005
First Posted: July 4, 2005
Last Update Posted: January 21, 2011
Last Verified: January 2011

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