October 31, 2009

A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease

This randomized, double-blind, placebo-controlled trial compared a strategy of initiating darbepoetin alfa at a threshold hemoglobin of 11.0 g per deciliter, with a goal of 13 g per deciliter, versus placebo, with rescue darbepoetin alfa when Hb fell below 9.0 g per deciliter. Patients studied included those with diabetes, CKD (defined as GFR 20-60 ml/min) and anemia. No difference was found in the overall rates of the primary end points.  The primary endpoints were 1) death or a cardiovascular event and 2) death or end-stage renal disease.

Of particular note, the patients assigned to darbepoetin alfa had a statistically and clinically significant increase in stroke.

This study is expected to drive much discussion and influence guidelines and clinical practice.

Related Articles:

Anemia, Chronic Kidney Disease
  • Is a stroke worth it?

  • Rudolph Easton

    While there was an increase in the secondary endpoint of stroke, this may have been found due to chance. We should not forget that ESAs in CKD will have an impact of quality of life scores as well as reduce transfusion requirements.

  • Sheila Saunders

    This study will be changing my clinical practice.

    Based on this well done randomized controlled trial, the Nephrology community will need to hesitate before starting ESAs in CKD patients with Hb > 9.

    At the very least, patients will need to be informed of the minimal benefit with regards to quality of life and the very real and heightened risk of stroke.