"National Kidney Foundation Releases Preliminary Anemia Guideline Update"

New Evidence Spurs Re-examination of 2006 Recommendations

Orlando, Florida
April 12, 2007

After reviewing new information about anemia management in chronic kidney disease (CKD), a National Kidney Foundation Kidney Disease Outcomes Quality Initiative^TM (KDOQI^TM) work group is today issuing a draft update to its 2006 Clinical Practice Guidelines on Anemia and CKD. The draft is being sent to over 1000 stakeholders for review and comment, prior to being finalized and published.

A key aspect of the new update is that the work group was able to clarify key aspects of a Hemoglobin (Hb) target for patients receiving Erythropoiesis Stimulating Agent (ESA) therapy . In the new statements, the work group recommends what factors should be considered in selecting a Hb target and states that the selected Hb target should generally be in the range 11.0 to 12.0 g/dL. They point out that because of natural fluctuations, actual Hb results will vary widely from Hb targets.

Also, after reviewing the latest results from six new randomized controlled trials about anemia management in chronic kidney disease (which doubled the number of CKD patients studied), the work group was able to upgrade one of its opinion-based statement to an evidence-based guideline recommending that, in dialysis and non-dialysis CKD patients receiving Erythropoiesis Stimulating Agent (ESA) therapy, the Hb target should not be above 13.0 g/dL.

"We want all clinicians who treat patients with chronic kidney disease to have guidelines based on the most up-to-date and reliable science available," says Mike Rocco, MD, Vice-chair of KDOQI^TM.

The work group -- made up of 16 volunteer experts in nephrology, hematology, epidemiology, nutrition, pharmacology, nursing, internal medicine and pediatrics -- previously worked for two-years analyzing peer-reviewed data on diagnosis and treatment of anemia at all stages of CKD. Their initial Guideline was published last May. The work group reunited on February 4, 2007, to update their initial recommendations taking into account the latest evidence and the studies included in the first Guidelines.

Anemia in end-stage renal disease (ESRD) is associated with increased mortality and hospitalization, decreased mental acuity, cardiac enlargement, heart failure, reduced health-related quality of life and impaired rehabilitation. "The work group clearly felt that the evidence is even stronger now that their initial recommendation to choose Hb targets below 13.0 g/dl is very appropriate for CKD patients," says Dr. Michael Rocco.

The recommendation to keep Hb targets below 13.0 g/dL is based on a review of all-cause mortality and adverse cardiovascular events in clinical trials where patients were assigned to Hb targets exceeding 13.0 g/dL. Evidence showing a trend toward greater number and severity of cardiovascular events in dialysis and non-dialysis patients assigned to Hb targets above13.0 g/dL was rated to be of moderately high quality for showing harm, and of high quality for showing lack of benefit.

"The statement about Hb targets above the 13.0 g/dL threshold reflects our judgment that greater weight should be given to potential harm than to uncertain benefit," says Dr. David Van Wyck, Co-Chair of the Work Group, who will present the update at the NKF's Spring Clinical Meetings. However, he pointed out that the work group agreed that further research is needed and should be encouraged.

The US Food and Drug Administration (FDA) has placed an upper limit for target Hb at 12.0 g/dL. Recently, the agency issued a black boxed warning for ESAs in light of new data that suggested non-dialysis CKD patients who were taking ESAs at doses designed to raise Hb to above 13 g/dL had a higher risk of death, blood clots, strokes, and heart attacks.