Supplementary Material for: Effects of extracorporeal blood flow rates on patient tolerance for LIXELLE® treatment during outpatient 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 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 United States (US).
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 one-week HD run-in, patients received LIXELLE plus HD at a blood flow rate of 250 mL/min (one week), followed by LIXELLE plus HD at a blood flow rate up to 450 mL/min (one week). These blood flow rates were tested with three LIXELLE column sizes in sequence (treatment = six 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 ratios and removal of select proteins (<40 kDa) increased with escalating column size and blood flow rate.
Conclusion: LIXELLE plus HD across all column sizes was safe and well-tolerated at blood flow rates up to 450 mL/min. Extent of B2M removal corresponded to column size-blood flow rate combinations. This EFS provides a risk profile to guide further studies of LIXELLE in ESKD patients at US-standard blood flow rates.