TREAT Trial

The TREAT trial was one of the bigger stories to emerge from this years ASN. This was a large, multicenter trial of darbepoeitin (Aranesp) vs. placebo in 4000 predialysis CKD patients with type 2 diabetes and anemia. The two groups did not differ in the two primary endpoints of all-cause death or cardiovascular event and death or end-stage renal disease and on the plus side, compared with placebo, treatment with Aranesp did result in some improvement in fatigue, less need for red-cell transfusions and a reduction in cardiac revascularization. However, there was also a significantly increased risk of fatal or nonfatal stroke (5% versus 2.6%; HR 1.92, 95% CI 1.38 to 2.68), which was not explained by systolic blood pressure.

The Aranesp group was treated to achieve a target hemoglobin of 13 g/dL, which is higher than I generally aim for, and it may be that a more restrictive dosing strategy could mitigate the risk of stroke. Even still, these findings create a lot of uncertainty and unease as to how best manage anemic CKD patients in the clinic.

As a footnote, this study also lends fuel to the growing literature on ESA’s driving the progression of cancer. In patients with a history of malignancy at baseline, cancer death was an order of magnitude more common in the darbepoetin group (7.4% versus 0.06%, P=0.002).