Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine120 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

End Stage Renal Disease on Dialysis

Interventions

pHA130 hemoperfusion device

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥18 years, with no restriction on gender; 2. Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months; 3. Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects. Exclusion Criteria: 1. Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment; 2. Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device; 3. Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding; 4. Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors; 5. Patients with a platelet count \< 60 × 10⁹/L; 6. Other conditions deemed unsuitable for enrollment in this study by the researchers.

Outcomes

Primary Outcomes

Serum indoxyl sulfate (IS)

value at 24 weeks minus value at baseline reported

Time frame: Week 0 to Week 24 (±7 days)

Serum p-cresyl sulfate (PCS)

value at 24 weeks minus value at baseline reported

Time frame: Week 0 to Week 24 (±7 days)

Secondary Outcomes

Parathyroid hormone (PTH)

Reduction rate of parathyroid hormone (PTH) before/after a single treatment session

Time frame: before/after a single treatment session

β2-microglobulin (β2-MG)

Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session.

Time frame: before/after a single treatment session

Serum indoxyl sulfate (IS)

Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session

Time frame: 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.

Time frame: before/after a single treatment session

Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score

Change in KDQOL-SF (Kidney Disease Quality of Life Short Form) total score from baseline to week 24.

Time frame: Week 0 to Week 24 (±7 days)

Pruritus severity score

Change from baseline in pruritus severity score (VAS and Modified Duo Pruritus Score) at Week 24.

Time frame: Week 0 to Week 24 (±7 days)

Pittsburgh Sleep Quality Index (PSQI)

Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 24

Time frame: Week 0 to Week 24 (±7 days)

Hospitalization rate

24-week hospitalization rate (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom hospitalization rate)

Time frame: Week 0 to Week 24 (±7 days)

Mortality rate

24-week-mortality (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom )

Time frame: Week 0 to Week 24 (±7 days)

Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts