6/30/23, 2:20 AM TREAT Pathway Feedback Search Clinical Topics Home Studies TREAT TREAT Disease Disease Disease Anemia of chronic kidney disease Chronic kidney disease Diabetes m Trial question What is the role of darbepoetin alfa in patients with T2DM and CKD, and anemia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 57.0% female N = 4038 43.0% male 4038 patients (2312 female, 1726 male) Inclusion criteria: patients with diabetes, CKD, and moderate anemia (Hgb level < 9.0 g/dL) who were not undergoing dialysis Key exclusion criteria: uncontrolled hypertension; previous kidney transplantation or scheduled receipt of a kidney transplant from a living related donor; current use of intravenous antibiotics, chemotherapy, or radiation therapy; diagnosed human immunodeficiency virus infection; active bleeding; a hematologic disease; or pregnancy Interventions N=2012 darbepoetin alfa (Aranesp, Amgen, to target Hgb level of approximately 13 g/dL) N=2026 placebo (matching placebo) https://web.pathway.md/studies/recu4mYJGtHCeHrD4 1/2 6/30/23, 2:20 AM TREAT Pathway Primary outcome Death or a cardiovascular event 31.4 % 31.4 29.7 23.5 % 15.7 % 7.8 % No significant difference 0.0 % Darbepoetin alfa Placebo No significant difference in death or a cardiovascular event (31.4% vs. 29.7%; HR 1.05, 95% CI 0.94 to 1.17) Secondary outcomes No significant difference in death or end-stage renal disease (32.4% vs. 30.5%; HR 1.06, 95% CI 0.95 to 1.19) Significant increase in fatal or nonfatal stroke (5% vs. 2.6%; HR 1.92, 95% CI 1.38 to 2.68) Significant decrease in cardiac revascularization (4.2% vs. 5.8%; HR 0.71, 95% CI 0.54 to 0.94) Safety outcomes Significant difference in change in patient-reported fatigue (54.7% vs. 49.5%,p = 0.002). Conclusion In patients with diabetes, CKD, and moderate anemia (Hgb level < 9.0 g/dL) who were not undergoing dialysis, darbepoetin alfa was not superior to placebo with respect to death or a cardiovascular event. Reference Pfeffer MA, Burdmann EA, Chen CY et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009 Nov 19;361(21):2019-32. Open reference URL https://web.pathway.md/studies/recu4mYJGtHCeHrD4 2/2