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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

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

Идентификаторы

NCT: NCT07016841 · XH-25-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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