Effects of Extracorporeal Blood Flow Rates on Patient Tolerance for LIXELLE<sup>®</sup> Treatment during Outpatient Hemodialysis

作者：Onkar S. Dhande, Arnaud Teichert, Varshasb Broumand, H. Kakita, Ayaka Kitamura, Masaaki Fukunishi, Christos Argyropoulos, Eva Czirr, Peter J. Nelson · 发表于：Blood Purification · 年份：2024 · DOI：10.1159/000536075 · 被引用次数：3 · 研究领域：Dialysis and Renal Disease Management、Acute Kidney Injury Research、Central Venous Catheters and Hemodialysis

INTRODUCTION: Accumulation of β2-microglobulin (B2M) in dialysis patients contributes to several comorbidities of end-stage kidney disease (ESKD). The LIXELLE® device adsorbs B2M from blood using sorbent bead technology. Studies in Japan showed that LIXELLE treatment during hemodialysis (HD) at blood flow rates up to 250 mL/min removes B2M above HD alone and is well tolerated. We investigated tolerance for LIXELLE treatment during HD at higher HD blood flow rates standard in the USA. METHODS: A prospective, open-label, non-randomized, single-arm, early-feasibility study (EFS) assessed tolerance and safety of LIXELLE treatment during HD at blood flow rates up to 450 mL/min. ESKD patients (40-75 years old) on thrice weekly outpatient HD were eligible. After a 1-week HD run-in, patients received LIXELLE plus HD at a blood flow rate of 250 mL/min (1 week), followed by LIXELLE plus HD at a blood flow rate up to 450 mL/min (1 week). These blood flow rates were tested with three LIXELLE column sizes in sequence (treatment = 6 weeks). B2M removal was assessed for each combination. RESULTS: Ten patients with a historic intradialytic hypotension (IDH) rate of 0.42 events/HD session/patient were enrolled. Nine patients completed all combinations without IDH events (treatment IDH rate: 0.56 events/HD session/patient). No treatment-emergent serious adverse events or significant changes in red blood cell, platelet, or complement indices except haptoglobin were reported. B2M reduction ratio...