This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD/HDF alone; HD/HDF plus biweekly pHA130 hemoperfusion; or HD/HDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.
Age ≥18 years, with no restriction on gender;
Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.
Cohort
Prospective
pHA130 hemoperfusion device
DeviceHP once every 2 weeks.
HD/HDF
DeviceHD twice weekly, HDF once weekly, with each session lasting 4 hours.
HA130 hemoperfusion device
DeviceHP once every 2 weeks.
Serum indoxyl sulfate (IS)
value at 24 weeks minus value at baseline reported
Serum p-cresyl sulfate (PCS)
value at 24 weeks minus value at baseline reported
Parathyroid hormone (PTH)
Reduction rate of parathyroid hormone (PTH) before/after a single treatment session
β2-microglobulin (β2-MG)
Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session.
Serum indoxyl sulfate (IS)
Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session
Serum p-cresyl sulfate (PCS)
Reduction rate of serum p-cresyl sulfate (PCS) before/after a single treatment session.
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