Study to Evaluate Effectiveness of Aranesp® - Full Text View

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117130

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 IV

Drug Information available for: Darbepoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Aranesp® Monthly Preference Study

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

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

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020147
Study First Received:	June 30, 2005
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00117130
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

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Renal Insufficiency, Chronic

Darbepoetin alfa
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Hematinics
Therapeutic Uses
Hematologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009