Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure

Patients with chronic kidney disease (CKD), particularly those on maintenance hemodialysis (MHD), face a high burden of cardiovascular disease and significantly impaired health-related quality of life. Traditional hemodialysis (HD) and hemodiafiltration (HDF) are effective at clearing small water-soluble molecules, but their efficacy in removing protein-bound uremic toxins (PBUTs)-such as indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-is notably limited. The accumulation of PBUTs is strongly associated with vascular calcification, increased cardiovascular mortality, and severe symptoms like uremic pruritus.

Hemoadsorption combined with hemodialysis (HAHD) has emerged as a promising strategy to address this gap. The novel pHA130 hemoadsorption cartridge features a modified resin with micro-controlled positive charges, enhancing its targeted adsorption capacity for PBUTs through electrostatic, hydrophobic, and molecular sieving mechanisms. In vitro studies have shown IS and PCS clearance rates exceeding 90%.

The PHOENIX trial is a prospective, open-label, multicenter, randomized controlled trial designed to evaluate the long-term clinical efficacy and safety of the pHA130 cartridge in MHD patients. Following a 4-week run-in period, eligible participants will be randomized 1:1 into two arms:

Experimental Group (HAHD): Receives high-flux HD twice a week and HAHD once a week. During HAHD, the pHA130 cartridge is placed in series before the high-flux dialyzer.

Control Group (HD): Receives conventional high-flux HD three times a week.

The primary endpoint is the percentage reduction in serum IS and PCS concentrations from baseline to 12 months. Secondary endpoints include changes in health-related quality of life (assessed by KDQoL-SF) and cognitive function (assessed by MMSE), progression of coronary artery calcification (CAC) measured by Agatston score, incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety metrics. The results of this study aim to provide robust evidence for optimizing blood purification strategies and improving long-term outcomes for patients with end-stage renal disease.

Inclusion criteria

• Age > 18 years.
• On maintenance hemodialysis for > 3 months.
• Receiving hemodialysis 3 times per week, 4 hours per session.
• Standard Kt/V ≥ 1.2.
• Voluntarily participates and provides written informed consent.

Exclusion criteria

• Known allergy to the dialyzer or hemoperfusion device.
• Platelet count < 60×10⁹/L.
• Serum albumin < 30 g/L.
• 24-hour urine output > 200 ml.
• Inability to achieve a blood flow rate ≥ 200 ml/min.
• Coagulation disorders, severe bleeding tendency, or active bleeding.
• Pre-dialysis systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg.
• Active malignancy.
• Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.
• Planned living-donor kidney transplant within the next 6 months.
• Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics.
• History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.