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
  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:


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:
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 April 17, 2014