What are the target levels for the correction of anemia of chronic disease and renal failure?

Updated: Nov 27, 2018
  • Author: Edgar V Lerma, MD, FACP, FASN, FAHA, FASH, FNLA, FNKF; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Answer

The optimal level of hemoglobin correction with ESA therapy in patients with anemia of CKD was addressed in two landmark trials published in 2006: the Cardiovascular Risk Reduction by Early Anemia Treatment with Epoetin Beta (CREATE) study [15]  and the Correction of Hemoglobin and Outcomes in Renal Insufficiency (CHOIR) study. [16]  Both provided evidence against full correction of the hemoglobin concentration (ie, to at least 13 g/dL).

As a result of the CREATE and CHOIR studies, in March 2007, the FDA added a black box warning to the labeling of epoetin alfa  and darbepoetin alfa to emphasize that use of these ESAs may increase the risk of serious cardiovascular events and death when they are dosed to achieve a target hemoglobin of greater than 12 g/dL. In November 2007, the FDA stated that "ESAs should be used to maintain a hemoglobin level between 10 g/dL to 12 g/dL. Maintaining higher hemoglobin levels in patients with chronic kidney failure increases the risk for death and for serious cardiovascular reactions such as stroke, heart attack or heart failure." [17]  

In 2011, the FDA abandoned the concept of a target range for the hemoglobin level in ESA treatment. Instead, the FDA recommended using the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions for each patient, and adjusting the dose as appropriate. [13]

The 2012 KDIGO guidelines recommend that in general, the hemoglobin level in adult patients with CKD should not be maintained above 11.5 g/dL; some patients may have improvements in quality of life at hemoglobin concentrations above 11.5 g/dL (115 g/l) and will be prepared to accept the risks, but hemoglobin should not exceed 13 g/dL. [14]  These goals are associated with lower mortality and less frequent hospitalization rates.

In pediatric CKD patients receiving ESA therapy, the KDIGO guidelines suggest a hemoglobin concentration in the range of 11.0 to 12.0 g/dL. However, National Kidney Foundation–Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) commentary on the guidelines recommends a range of 11-13 g/dL, to avoid the need for multiple dosing adjustments. [14]


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