The purpose of this study is to determine whether darbepoetin alfa manufactured by the current "roller bottle" technology and darbepoetin alfa manufactured by a serum free process have a comparable safety profile.

Condition	Treatment or Intervention	Phase
Kidney Disease Chronic Disease	Drug: darbepoetin alfa	Phase III

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Currently diagnosed with Chronic Kidney Disease, either receiving or not receiving dialysis
• Anemic
• Currently on erythropoietic therapy
• Controlled hypertension
• Clinically stable

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Arizona
      Research Site, Tucson,  Arizona,  United States; Recruiting
Florida
      Research Site, Pembroke Pines,  Florida,  United States; Recruiting
      Research Site, Tampa,  Florida,  United States; Recruiting
Hawaii
      Research Site, Honolulu,  Hawaii,  United States; Recruiting
Louisiana
      Research Site, Shreveport,  Louisiana,  United States; Recruiting
New York
      Research Site, Brooklyn,  New York,  United States; Recruiting
      Research Site, Flushing,  New York,  United States; Recruiting
      Research Site, Williamsville,  New York,  United States; Recruiting
Oregon
      Research Site, Portland,  Oregon,  United States; Recruiting
Pennsylvania
      Research Site, Mansfield,  Pennsylvania,  United States; Recruiting
Texas
      Research Site, San Antonio,  Texas,  United States; Recruiting
Virginia
      Research Site, Fairfax,  Virginia,  United States; Recruiting

Study ID Numbers:  20040180
Record last reviewed:  October 2004
Record first received:  October 7, 2004
ClinicalTrials.gov Identifier:  NCT00093977
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10