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

Official title

Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study

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.

Interventions

• Device pHA130 hemoperfusion device
  HP once every 2 weeks.
• Device HD/HDF
  HD twice weekly, HDF once weekly, with each session lasting 4 hours.
• Device HA130 hemoperfusion device
  HP once every 2 weeks.

Primary outcome measures

• Serum indoxyl sulfate (IS) [Time frame: Week 0 to Week 24 (±7 days)]
• Serum p-cresyl sulfate (PCS) [Time frame: Week 0 to Week 24 (±7 days)]

Secondary outcome measures (9)

• Parathyroid hormone (PTH) [Time frame: before/after a single treatment session]
• β2-microglobulin (β2-MG) [Time frame: before/after a single treatment session]
• Serum indoxyl sulfate (IS) [Time frame: before/after a single treatment session]
• Serum p-cresyl sulfate (PCS) [Time frame: before/after a single treatment session]
• Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score [Time frame: Week 0 to Week 24 (±7 days)]
• Pruritus severity score [Time frame: Week 0 to Week 24 (±7 days)]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: Week 0 to Week 24 (±7 days)]
• Hospitalization rate [Time frame: Week 0 to Week 24 (±7 days)]
• Mortality rate [Time frame: Week 0 to Week 24 (±7 days)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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;
• Patients with a platelet count < 60 × 10⁹/L;
• Other conditions deemed unsuitable for enrollment in this study by the researchers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

China · 1 center

• Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07016841 · XH-25-005

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗