Abstract: SA-PO1073
Improved Middle Molecule Clearance with Preserved Albumin Levels Using the ELISIO-HX Medium Cut-Off Hemodialyzer
Session Information
- Kidney Replacement Therapy and Care Delivery Innovations
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Dhillon, Kiranjit K., Tidewater Tech, Norfolk, Virginia, United States
- Sylvestre, Joanne, Tidewater Tech, Norfolk, Virginia, United States
Background
Conventional high-flux hemodialysis provides limited clearance of larger middle molecules associated with poor outcomes in ESRD. ELISIO™-HX is an MCO polyethersulfone dialyzer designed to improve middle molecule removal while minimizing albumin loss. This study evaluated the safety and performance of ELISIO™-HX in maintenance hemodialysis patients.
Methods
This prospective, single-center, single-arm, open-label IDE study enrolled adults receiving maintenance in-center hemodialysis. Following baseline treatment with a standard high-flux dialyzer (ELISIO-H), participants received ELISIO™-HX three times weekly for 12 weeks.
The primary efficacy endpoint was change in post-dialysis reduction ratio (RR) of lambda free light chains (λ-FLC, 45 kDa) at Week 12 versus baseline. The primary safety endpoint was change in serum albumin from baseline to Week 12. Secondary endpoints included clearance of additional middle molecules, Kt/V, laboratory safety parameters, adverse events, and KDQOL-36.
Results
Eighteen participants were enrolled and 13 completed all 36 study treatments. Mean age was 55.5 years; 55.6% were male and 72.2% were Black or African American. At Week 12 ELISIO™-HX demonstrated significantly improved λ-FLC removal versus baseline treatment with ELISIO-H, with a mean RR change of −11.2% (95% CI: −20.4%, −2.0%). Additional improvements in middle molecular clearance trends were also observed for TNFα, Complement Factor D, κ-FLC, and β2-Microglobulin. IL-6 and myoglobin did not demonstrate statistically significant changes. Dialysis adequacy remained stable throughout the study with mean single-pool Kt/V approximately 1.4 across all visits. Serum albumin remained stable over 12 weeks with a mean change from baseline of −0.04 g/dL (95% CI: −0.29, 0.21). No deaths, device-related adverse or unanticipated adverse device effects were reported. Procedure-related adverse events, primarily muscle spasms and hypotension, were consistent with those expected in patients undergoing maintenance hemodialysis.
Conclusion
Treatment with the ELISIO™-HX MCO dialyzer improved clearance of middle molecular weight uremic toxins while maintaining albumin levels and demonstrating an acceptable safety profile over 12 weeks. These findings support ELISIO™-HX as a promising advancement in hemodialysis therapy, and a potential alternative for patients who are not candidates for hemodiafiltration.
Funding
- Commercial Support – Nipro