Abstract: TH-PO1288
Clinical Evaluation of a Novel Polyethersulfone Hemodiafiltration Filter: A Multicenter Randomized Crossover Noninferiority Trial
Session Information
- Late-Breaking Research Posters
October 22, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Liu, Fanna, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China
- Tang, Ying, Southern Medical University, Guangzhou, Guangdong, China
- Chen, Liangmei, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China
- Yang, Jianwei, Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China
Background
Hemodiafiltration (HDF) removes small- and middle-molecule uremic toxins via diffusion and convection. Dialyzer membrane characteristics govern HDF outcomes. Heavy reliance on imported high-performance dialyzers raises medical costs and limits HDF application in China. A novel domestic polyethersulfone-based filter B-18AHDF was developed, yet rigorous randomized controlled evidence is lacking. This randomized crossover non-inferiority trial compared its solute-clearing efficacy and safety against the widely used imported FX80 filter in maintenance hemodialysis patients.
Methods
This multicenter, open-label crossover non-inferiority study enrolled 92 patients from two university-affiliated hospitals from October 2024 to July 2025 (registration pending). Subjects were randomly assigned to receive B-18AHDF (Bain Medical) and FX80 (Fresenius) alternately with a wash-out interval via 1:1 centralized concealed randomization. Efficacy was analyzed using the full-analysis set (FAS) and per-protocol set (PPS), while safety was assessed in the safety set (SS). Primary endpoints included urea clearance, creatinine clearance and β2-microglobulin (β2-MG) reduction rate, with non-inferiority margins of −20 mL/min, −16 mL/min and −6%. Non-inferiority was confirmed if the lower limit of the 95% confidence interval (CI) for the between-group difference exceeded the predefined boundary. Adverse events, laboratory parameters and biocompatibility indexes were evaluated for safety.
Results
The B-18AHDF filter satisfied non-inferiority criteria for all primary endpoints. In total, 88 out of 92 participants completed the dialysis assessment. Mean differences between B-18AHDF and FX80 for urea clearance, creatinine clearance and β2-MG reduction rate were 1.24 mL/min (95%CI 2.20-4.68), 0.24 mL/min (95%CI 2.99-3.46) and 11.51% (95%CI 9.72-13.30). Notably, B-18AHDF achieved significantly better β2-MG elimination (P < 0.0001). The urea reduction ratio (URR) was also higher in the test group (71.28% vs 70.21%, P < 0.0001). No statistically significant differences were observed in safety outcomes between groups.
Conclusion
B-18AHDF exhibits non-inferior solute removal and comparable safety versus FX80, with prominent advantages in clearing middle-molecule toxins. This domestic filter can serve as a cost-effective alternative for clinical HDF treatment.
Acknowledgment
The authors declare that Bain Medical is the sponsor of this Phase-3 trial. None of the authors are employees of Bain Medical, and the authors have no other conflicts of interest.
Funding
- Commercial Support – Bain Medical is the sponsor of this Phase-3 trial