Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT)

Trial to Reduce Cardiovascular Events With Aranesp® Therapy

The purpose of this study is to assess the impact of treatment of anemia with darbepoetin alfa to a hemoglobin target of 13 g/dL on (1) all-cause mortality and nonfatal cardiovascular events, and (2) progression to end-stage renal disease or death, in subjects with chronic kidney disease and type 2 diabetes mellitus.

Academic PI/Executive Committee Chairman: Marc Pfeffer, MD, PhD

Inclusion Criteria:

• Hemoglobin less than or equal to 11 g/dL
• History of Chronic Kidney Disease
• eGFR (estimated glomerular filtration rate) greater than or equal to 20 mL/min/1.73 m2 and less than or equal to 60 mL/min/1.73 m2
• Tsat (transferrin saturation) greater than 15%

Exclusion Criteria:

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