This publication of the Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia represents the second update of these guidelines since the first guideline on this topic was published in 1997. The first set of guidelines established the importance of hemoglobin in dialysis patients, and established guidelines and targets for the treatment of anemia in dialysis patients. The first update, published in 2000, described anemia in a wider spectrum of the chronic kidney patients, and included those not on dialysis.
A number of important randomized clinical trials and large observational studies have been commenced or completed in CKD populations both on and off dialysis, over the past 5 years. The key questions that have been addressed in these recent studies have been the optimal hemoglobin target for CKD patients. To date there has been little support normalizing hemoglobin, though a number of important studies have not been completed or reported (CHOIR and TREAT), and the community eagerly awaits them. Nonetheless, the key aspects of the published data from both controlled trials and observational studies, support the ongoing importance of hemoglobin levels in risk stratification of patients with CKD, whether with native or transplant kidneys, or on dialysis therapies. Much has been learned about the causes of erythropoietin resistance, and some small studies have reported methods of treating ESA resistance. Furthermore, there are multiple new insights into the optimizing treatment of anemia with iron supplementation and ESA. Novel actions of ESAs on cognitive function, as well as preservation of kidney and cardiac function have been described. To date there are no clinical trials to support the use of ESA for these 'non anemia' purposes, but both the basic and clinical science of ESA therapy are advancing at a rapid pace.
This updated set of guidelines on anemia is unique and different from the previous anemia guidelines. Firstly, the guidelines have been separated into evidence based guidelines and clinical practice recommendations, based on the strength of evidence. The term guideline is reserved for that which is robust enough to be used, if appropriate, as a clinical performance measure. Clinical practice recommendations are those recommendations based on expert opinion of the working group, but lacking sufficient hard data; CPRs are also susceptible to testing in a clinical trial. Secondly, these guidelines incorporated individuals from countries outside the US (Europe, UK, Middle East, Mexico and Canada) and attempted to build on most recently published European Best Practice guidelines (2004), as well as the previously published KDOQI versions. Lastly, the working group was clearly focused on ensuring that this document was robust and clear for the reader. There was an overt recognition that research recommendations should be organized and described in sufficient detail to ensure that prior to the next update of any anemia guideline, there would be new data addressing gaps in our current knowledge. Thus, there are no concrete research recommendations in this version; they will be published in a separate document in the near future. The intended effect of this change in how the research recommendations are presented is to provide a guidepost for funding agencies and investigators to target research efforts in those areas that will provide important information that will benefit patient outcomes.
This final version of the Clinical Practice Guidelines and Recommendations for Anemia has undergone revision in response to comments during the public review, an important and integral part of the KDOQI guideline process. Nonetheless, as with all guideline documents, there is a need for revision in the light of new evidence, and more importantly, a concerted effort to translate the guidelines into practice. Considerable effort has gone into their preparation over the past 2 years, and every attention has been paid to their detail and scientific rigor, no set of guidelines and clinical practice recommendations, no matter how well developed, achieves its purpose unless it is implemented and translated into clinical practice. Implementation is an integral component of the KDOQI process, and accounts for the success of its past guidelines. The Kidney Learning System (KLS) component of the National Kidney Foundation is developing implementation tools that will be essential to the success of these guidelines.
In a voluntary and multidisciplinary undertaking of this magnitude, many individuals make contributions to the final product now in your hands. It is impossible to acknowledge them individually here, but to each and every one of them we extend our sincerest appreciation. This limitation notwithstanding a special debt of gratitude is due to the members of the Work Group, and their co-chairs, David Van Wyck and Kai-Uwe Eckardt. It is their commitment and dedication to the KDOQI process that has made this document possible.
Adeera Levin, MD
KDOQI Chair
Michael Rocco, MD
KDOQI Vice-Chair