TREAT. A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. NEJM 2009; 361: 2019.
Background: Study of the outcome effect of increasing hemoglobin levels in patients with type 2 diabetes and CKD.
Methods: Multi-national, randomized, double-blind, placebo-controlled trial. Included patients with DM2, CKD (GFR 20-60 [MDRD]), anemia (Hb < 11.0), and transferrin saturation of 15%. Excluded uncontrolled HTN, kidney transplant, current use of IV ABx, chemo, XRT, cancer (x BCCA or SCCA of the skin), HIV, active bleeding, heme disorder, or pregnancy. n = 4038.
Treatment: darbepoetin alfa to achieve Hb of 13 g/dL v rescue darbepoetin when Hb < 9.0.
Results: darbepoetin v placebo
Death (any cause): 20.5 v 19.5%, p = 0.48
MI: 6.2 v 6.4%, p = 0.73
Stroke: 5.0 v 2.6, p = <0.001, NNH = 42
Heart failure: 10.2 v 11.3, p = 0.24
Myocardial ischemia: 2.0 v 2.4, p = 0.40
ESRD: 16.8 v 16.3, p = 0.83
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