This study will assess the effect of anemia therapy with darbepoetin alfa on the composite event comprising all-cause mortality and cardiovascular (CV) events in subjects with both chronic kidney disease (CKD) and type 2 diabetes mellitus (DM).

Condition	Treatment or Intervention	Phase
Kidney Diseases Nephritis Diabetes Mellitus	Drug: darbepoetin alfa	Phase III

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

Criteria

Inclusion Criteria:

• Signed, written informed consent
• Hb ≤ 11.0 g/dL
• Chronic Kidney Disease (CKD)
• Type 2 diabetes mellitus (DM)

Exclusion Criteria:

• A prior kidney transplant or be anticipating or scheduled for a living related-donor kidney transplant
• Uncontrolled hypertension
• Iron Deficiency
• History of CV events within 12 weeks prior to randomization

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Alabama
      Research Site, Birmingham,  Alabama,  United States; Recruiting
      Research Site, Huntsville,  Alabama,  United States; Recruiting
      Research Site, Mobile,  Alabama,  United States; Recruiting
Arizona
      Research Site, Glendale,  Arizona,  United States; Recruiting
      Research Site, Mesa,  Arizona,  United States; Recruiting
      Research Site, Phoenix,  Arizona,  United States; Recruiting
      Research Site, Tucson,  Arizona,  United States; Recruiting
Arkansas
      Research Site, Harrisburg,  Arkansas,  United States; Recruiting
      Research Site, Little Rock,  Arkansas,  United States; Recruiting
California
      Research Site, Los Banos,  California,  United States; Recruiting
      Research Site, Los Gatos,  California,  United States; Recruiting
      Research Site, Moreno Valley,  California,  United States; Recruiting
      Research Site, Cerritos,  California,  United States; Recruiting
      Research Site, Dinuba,  California,  United States; Recruiting
      Research Site, Duarte,  California,  United States; Recruiting
      Research Site, Fresno,  California,  United States; Recruiting
      Research Site, Fullerton,  California,  United States; Recruiting
      Research Site, Huntington Beach,  California,  United States; Recruiting
      Research Site, La Jolla,  California,  United States; Recruiting
      Research Site, Long Beach,  California,  United States; Recruiting
      Research Site, Los Angeles,  California,  United States; Recruiting
      Research Site, Modesto,  California,  United States; Recruiting
      Research Site, Oakland,  California,  United States; Recruiting
      Research Site, Pasadena,  California,  United States; Recruiting
      Research Site, Redondo Beach,  California,  United States; Recruiting
      Research Site, Redwood City,  California,  United States; Recruiting
      Research Site, Roseville,  California,  United States; Recruiting
      Research Site, Sacramento,  California,  United States; Recruiting
      Research Site, Santa Barbara,  California,  United States; Recruiting
      Research Site, West Hills,  California,  United States; Recruiting
      Research Site, Lancaster,  California,  United States; Recruiting
Colorado
      Research Site, Thornton,  Colorado,  United States; Recruiting
Connecticut
      Research Site, Stamford,  Connecticut,  United States; Recruiting
Florida
      Research Site, Brandon,  Florida,  United States; Recruiting
      Research Site, Cape Coral,  Florida,  United States; Recruiting
      Research Site, Charlotte Harbour,  Florida,  United States; Recruiting
      Research Site, Hollywood,  Florida,  United States; Recruiting
      Research Site, Jacksonville,  Florida,  United States; Recruiting
      Research Site, Jacksonville Beach,  Florida,  United States; Recruiting
      Research Site, Melbourne,  Florida,  United States; Recruiting
      Research Site, New Port Richey,  Florida,  United States; Recruiting
      Research Site, Pembroke Pines,  Florida,  United States; Recruiting
      Research Site, Plantation,  Florida,  United States; Recruiting
      Research Site, Port Charlotte,  Florida,  United States; Recruiting
      Research Site, St. Petersburg,  Florida,  United States; Recruiting
      Research Site, Sarasota,  Florida,  United States; Recruiting
Georgia
      Research Site, Atlanta,  Georgia,  United States; Recruiting
      Research Site, Augusta,  Georgia,  United States; Recruiting
      Research Site, Conyers,  Georgia,  United States; Recruiting
Illinois
      Research Site, Chicago,  Illinois,  United States; Recruiting
Indiana
      Research Site, Indianapolis,  Indiana,  United States; Recruiting
Iowa
      Research Site, Des Moines,  Iowa,  United States; Recruiting
Kansas
      Research Site, Wichita,  Kansas,  United States; Recruiting
Kentucky
      Research Site, Louisville,  Kentucky,  United States; Recruiting
Louisiana
      Research Site, Baton Rouge,  Louisiana,  United States; Recruiting
      Research Site, Bossier City,  Louisiana,  United States; Recruiting
      Research Site, New Orleans,  Louisiana,  United States; Recruiting
Maryland
      Research Site, Glen Burnie,  Maryland,  United States; Recruiting
      Research Site, Rockville,  Maryland,  United States; Recruiting
Massachusetts
      Research Site, Boston,  Massachusetts,  United States; Recruiting
      Research Site, Needham,  Massachusetts,  United States; Recruiting
      Research Site, Worcester,  Massachusetts,  United States; Recruiting
Michigan
      Research Site, Benzonia,  Michigan,  United States; Recruiting
      Research Site, Oak Park,  Michigan,  United States; Recruiting
      Research Site, Royal Oak,  Michigan,  United States; Recruiting
      Research Site, Troy,  Michigan,  United States; Recruiting
Missouri
      Research Site, Chesterfield,  Missouri,  United States; Recruiting
      Research Site, Kansas City,  Missouri,  United States; Recruiting
      Research Site, St. Louis,  Missouri,  United States; Recruiting
Nebraska
      Research Site, Springfield,  Nebraska,  United States; Recruiting
Nevada
      Research Site, Las Vegas,  Nevada,  United States; Recruiting
New Jersey
      Research Site, Medford,  New Jersey,  United States; Recruiting
      Research Site, Roseland,  New Jersey,  United States; Recruiting
New York
      Research Site, Amherst,  New York,  United States; Recruiting
      Research Site, Bronx,  New York,  United States; Recruiting
      Research Site, Buffalo,  New York,  United States; Recruiting
      Research Site, Cortland Manor,  New York,  United States; Recruiting
      Research Site, Flushing,  New York,  United States; Recruiting
      Research Site, Hamburg,  New York,  United States; Recruiting
      Research Site, Hewlett,  New York,  United States; Recruiting
      Research Site, Kingston,  New York,  United States; Recruiting
      Research Site, New Hartford,  New York,  United States; Recruiting
      Research Site, New York,  New York,  United States; Recruiting
      Research Site, Northport,  New York,  United States; Recruiting
North Carolina
      Research Site, Asheville,  North Carolina,  United States; Recruiting
      Research Site, Cary,  North Carolina,  United States; Recruiting
      Research Site, Gastonia,  North Carolina,  United States; Recruiting
      Research Site, Greensboro,  North Carolina,  United States; Recruiting
      Research Site, Greenville,  North Carolina,  United States; Recruiting
      Research Site, Statesville,  North Carolina,  United States; Recruiting
      Research Site, Wilmington,  North Carolina,  United States; Recruiting
Ohio
      Research Site, Cincinnati,  Ohio,  United States; Recruiting
      Research Site, Columbus,  Ohio,  United States; Recruiting
Pennsylvania
      Research Site, Aliquippa,  Pennsylvania,  United States; Recruiting
      Research Site, Allentown,  Pennsylvania,  United States; Recruiting
      Research Site, Media,  Pennsylvania,  United States; Recruiting
      Research Site, Monongahela,  Pennsylvania,  United States; Recruiting
      Research Site, Norristown,  Pennsylvania,  United States; Recruiting
      Research Site, Philadelphia,  Pennsylvania,  United States; Recruiting
      Research Site, Uniontown,  Pennsylvania,  United States; Recruiting
      Research Site, Verona,  Pennsylvania,  United States; Recruiting
      Research Site, West Chester,  Pennsylvania,  United States; Recruiting
Tennessee
      Research Site, Memphis,  Tennessee,  United States; Recruiting
Texas
      Research Site, Corpus Christi,  Texas,  United States; Recruiting
      Research Site, Amarillo,  Texas,  United States; Recruiting
      Research Site, Austin,  Texas,  United States; Recruiting
      Research Site, Beaumont,  Texas,  United States; Recruiting
      Research Site, Dallas,  Texas,  United States; Recruiting
      Research Site, El Paso,  Texas,  United States; Recruiting
      Research Site, Irving,  Texas,  United States; Recruiting
      Research Site, Lubbock,  Texas,  United States; Recruiting
      Research Site, San Antonio,  Texas,  United States; Recruiting
      Research Site, Sugar Land,  Texas,  United States; Recruiting
Utah
      Research Site, Salt Lake City,  Utah,  United States; Recruiting

Study ID Numbers:  20010184
Record last reviewed:  October 2004
Record first received:  September 28, 2004
ClinicalTrials.gov Identifier:  NCT00093015
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-27