Abstract: FR-PO0502
pHA130 Electrostatic Hemoadsorption System: A Material-to-Clinic Approach for Precision Removal of Protein-Bound Uremic Toxins
Session Information
- Dialysis: Hemodiafiltration, Ultrafiltration, Profiling, and Interdialytic Symptoms
November 07, 2025 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- 801 Dialysis: Hemodialysis and Frequent Dialysis
Authors
- Cheng, Wang, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
- Jianting, Ke, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
- Yuting, Wei, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
- Ying, Guo, Zhujiang Hospital of Southern Medical University, Guangzhou, Guangdong, China
- Qizhan, Lin, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
- Li, Zhongxin, Beijing Luhe Hospital Affiliated to Capital Medical University, Beijing, China
- Nan, Gong, Handan Central Hospital, Handan, Hebei, China
- Jihao, Hu, The Fifth Affiliated Hospital of Sun Yat-sen University, Zhuhai, Guangdong, China
- Hu, Liu, Jafron Biomedical Co., Ltd, Zhuhai, Guangdong, China
- Ke, Shao, Jafron Biomedical Co., Ltd, Zhuhai, Guangdong, China
- Yanhui, Gong, Jafron Biomedical Co., Ltd, Zhuhai, Guangdong, China
- Wenkai, Xiao, Jafron Biomedical Co., Ltd, Zhuhai, Guangdong, China
Background
Protein-bound uremic toxins (PBUTs), such as indoxyl sulfate (IS) and p-cresyl sulfate (PCS), accumulate in kidney failure patients, increasing cardiovascular risk and mortality. Conventional hemodialysis is ineffective at removing these toxins due to their high albumin-binding affinity (90–95%). We developed the novel pHA130 Electrostatic Hemoadsorption System and evaluated its safety and efficacy through both in vitro and clinical studies.
Methods
A three-tiered validation framework was implemented:
1. Material characterization: Resin morphology, porous structures, and chemical groups were analyzed using SEM, XPS, and BET.
2. In vitro assays:Oscillatory experiments(37°C, 140 rpm) tested IS/PCS removal; Platelet adhesion, leukocyte counts, and complement activation evaluated hemocompatibility.
3. Clinical study: A multicenter RCT enrolling 220 MHD patients randomized to pHA130 (n=111) or HA130 (n=109) combined with hemodialysis. Primary endpoints: toxin reduction rates (single-session IS and PCS pre/post levels) and safety profiles (adverse events).
Results
1. Material properties:pHA130 resin showed spherical morphology with radially gradient pores (abundant <5 nm micropores and 40–70 nm meso/macropores). XPS confirmed quaternary ammonium groups enabling electrostatic adsorption of negatively charged PBUTs.
2. In vitro performance:
Clearance efficiency:pHA130 vs. HA130: IS (88.48%±0.56% vs. 27.64%±0.82%, P<0.001); PCS (89.46%±2.57% vs. 35.89%±1.72%, P<0.001).
Hemocompatibility: Minimal platelet adhesion, stable leukocyte counts ([5.24±0.07]×109/L vs. [5.14±0.03]×109/L, P=0.048), and comparable complement activation (sC5b-9: 11.70±0.42 vs. 11.89±0.39 ng/mL, P=0.38).
3. Clinical outcomes:
Toxin reduction: Compared with HA130, pHA130 achieved significantly greater reduction rates in IS (45.51% ± 13.75% vs. 31.97% ± 20.91%, P < 0.001) and PCS (40.55% ± 12.96%, vs. 28.21% ± 19.78%, P <0.001).
Safety: Adverse event rates were comparable between pHA130 (14.41%) and HA130 (16.51%) groups (P=0.712).
Conclusion
The pHA130 Electrostatic Hemoadsorption System demonstrated safety and efficacy of protein-bound toxin removal by in vitro performance, and clinical study, further long-term studies are needed to confirm its role in patients with hemodialysis.
Funding
- Commercial Support – Jafron Biomedical Co., Ltd