Trial to Reduce Cardiovascular Events With ‘Aranesp’ Therapy (TREAT)

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