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Study to Evaluate Effectiveness of Aranesp®

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00117130
First received: June 30, 2005
Last updated: January 20, 2011
Last verified: January 2011
History of Changes
  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: Open Label
Primary Purpose: Treatment
Official Title: Aranesp® Monthly Preference Study

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00117130

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

Additional Information:
AmgenTrials clinical trials website  This link exits the ClinicalTrials.gov site
Notice regarding posted summaries of trial results  This link exits the ClinicalTrials.gov site
To access clinical trial results information click on this link  This link exits the ClinicalTrials.gov site
FDA-approved Drug Labeling  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT00117130     History of Changes
Other Study ID Numbers: 20020147
Study First Received: June 30, 2005
Last Updated: January 20, 2011
Health Authority: United States: Institutional Review Board

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
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 13, 2013