More than 400,000 people are currently treated by hemodialysis (HD) under the auspices of the U.S. End-stage Renal Disease (ESRD) program. The mortality in this group of patients is unacceptably high. Many mortality risk factors, such as age, gender, ethnic background, and presence of diabetes are not modifiable. A majority of the deaths are due to cardiovascular diseases, followed by infectious complications and malnutrition. Strategies to reduce the mortality of patients, including those directed at cardiovascular risk factors, such as treatment of dyslipidemia, largely have not been effective.
Inflammation has been implicated in the pathogenesis of atherosclerotic cardiovascular disease, as well as malnutrition, and has been shown, using diverse measures, to be linked to increased mortality in HD patients for over a decade. Therapeutic interventions, such as biologic therapies directed against dysregulation of cytokine biology, however, have not been tested in large randomized controlled trials in the ESRD population. The benefits and adverse consequences of combined anti-inflammatory therapies are unknown, and need to be tested in diverse patient groups before large randomized controlled trials can be initiated. It is likely because of the redundancy and pleiotropy of the inflammatory response that multiple interventions will be required, but there are concerns regarding adverse effects with such strategies. There is, however, potential for public/private collaboration in such studies.
Novel Therapies to Enhance ESRD Patient Survival will address inflammation and anti-inflammatory cytokine responses, malnutrition, and cardiovascular disease in the context of ESRD patient morbidity and mortality. The workshop will develop recommendations regarding the types of research necessary to advance the field, a hierarchy of interventions, and delineate the number of subjects necessary for effective trials.