[The need to revise the hemoglobin threshold value in the German Quality Assurance Directive for Dialysis]

The German Quality Assurance Directive for Dialysis (QSD-RL) stipulates that no more than 15 % of all patients treated in a dialysis unit in any quarter may have a hemoglobin (Hb) value lower than 10 g/dl. For approximately 90 % of dialysis patients, this Hb threshold value can be simply achieved by administering erythropoiesis-stimulating agents (ESA). However, the question is raised as to wether this Hb threshold accords with the current state of knowledge. It is now evident from four randomized controlled trials (above all the TREAT study) and three meta-analyses that an ESA-induced increase in Hb does not produce any significant survival benefit in cases of chronic kidney disease (CKD), but may actually be detrimental. Critical attention must be focused in this regard on the higher risk of cardiovascular and cerebrovascular events, as well as malignoma-associated risks. In 2011, in response to these findings, the American Food and Drug Administration (FDA), the Drug Directive (AM-RL) of the German Federal Joint Committee and KDIGO (Kidney Disease: Improving Global Outcomes) amended guidelines for the treatment of renal anemia. Very restrictive recommendations were made regarding the use of ESA in CKD, according to which the Hb threshold value of 10 g/dl stipulated in the Quality Assurance Directive is now obsolete, thus necessitating prompt revision of the Directive. Two alternatives are available in this regard: either the 10 g/dl Hb threshold value applicable hitherto is withdrawn without replacement, and individualized treatment of renal anemia is practised ("individualization") instead, or a threshold value of 9 g/dl (modified "standardization") is applied in future.