Aranesp® Monthly Preference Study - 2

This study has been completed.

First Received: June 30, 2005 Last Updated: September 29, 2008 History of Changes

Sponsored by:	Amgen
Information provided by:	Amgen
ClinicalTrials.gov Identifier:	NCT00117078

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 - 2

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117078

Sponsors and Collaborators

Amgen

Investigators

Study Director:

Amgen

More Information

Additional Information:

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

AmgenTrials clinical trials website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amgen Inc. ( Global Development Leader )
Study ID Numbers:	20020380
Study First Received:	June 30, 2005
Last Updated:	September 29, 2008
ClinicalTrials.gov Identifier:	NCT00117078 History of Changes
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
Hematinics
Renal Insufficiency, Chronic

Darbepoetin alfa
Kidney Failure, Chronic
Kidney Diseases

Additional relevant MeSH terms:

Urologic Diseases
Hematinics
Therapeutic Uses
Hematologic Agents

Darbepoetin alfa
Kidney Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009