The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa on mortality and cardiovascular morbidity in patients with chronic kidney disease and type 2 diabetes.

Official Title

Conditions

Kidney Disease, Nephritis, Diabetes Mellitus, anaemia

Study Type

Interventional

Study Design

Treatment

Further Details

Primary Outcome Measures:

  • Mortality
  • Cardiovascular morbidity (TIA, MI, CHF, CVA, myocardial ischemia)

Secondary Outcome Measures:

  • Time to all-cause mortality
  • Time to cardiovascular mortality
  • Time to MI
  • Time to CVA
  • Time to CHF
  • Time to ESRD
  • Rate of decline in eGFR relative to baseline
  • Change in patient reported fatigue relative to baseline at week 25

Study Start

Eligibility & Criteria

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

Inclusion Criteria:

  • Hemoglobin less than or equal to 11 g/dL
  • History of Chronic Kidney Disease
  • eGFR greater than or equal to 20 mL/min and less than or equal to 60 mL/min
  • Tsat greater than 15%

Exclusion Criteria:

  • Uncontrolled hypertension
  • Erythropoietic protein use within 12 weeks of randomization
  • Total Enrolment

    Contact Details

    More information available from AmgenTrials

    • Research Site, Nedlands, Western Australia, Australia; Recruiting
    • Research Site, Woodville, South Australia, Australia; Recruiting

    Published report results