End-Stage Renal Disease (ESRD) Clinical Trial
Official title:
Improvement of EPO-resistance in HD Patients With Chronic Inflammation by High Cut-off Hemodialysis - Pilot Study (CIEPO-PILOT)
Chronic inflammation in dialysis patients is linked to cardiovascular mortality and clinical signs and symptoms, like the impaired response to erythropoiesis-stimulating agents (ESAs). This study aims to demonstrate that high cut-off hemodialysis is effective in reducing chronic inflammation and thereby improving response to ESAs.
Chronic inflammation in hemodialysis patients (micro-inflammation) is caused by multiple
inflammatory stimuli and becomes apparent by elevated levels of biochemical markers such as
CRP, IL-6, cellular activation markers etc. Chronic inflammation is linked to clinical signs
and symptoms and cardiovascular mortality in dialysis patients. Inflamed dialysis patients
show impaired response to erythropoiesis-stimulating agents (ESA) related to reduced iron
utilization (functional iron deficiency) and elevated CRP levels are associated with a
greater need for ESA to meet hemoglobin targets. If absolute iron deficiency can been
excluded, EPO resistance is likely related to 'inflammatory block'.
The high molecular permeability of the Theralite high cut-off membrane allows for
significant clearance of cytokines and other pro-inflammatory solutes by hemodialysis as
shown in previous trials with high cut-off dialyzers. The study therefore aims to
demonstrate that Theralite dialysis is effective in reducing chronic inflammation in ESRD
patients, thereby improving EPO responsiveness. If this can be demonstrated, application of
Theralite hemodialysis may reduce morbidity and mortality in the long term in ESRD patients.
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