Clinical trial NCT07016841: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End Stage Renal Disease on Dialysis
Keywords: Hemoadsorption
Hemodialysis
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum indoxyl sulfate (IS)
timeFrame: Week 0 to Week 24 (±7 days)
measure: Serum p-cresyl sulfate (PCS)
timeFrame: Week 0 to Week 24 (±7 days)
Secondary outcomes:
measure: Parathyroid hormone (PTH)
timeFrame: before/after a single treatment session
measure: β2-microglobulin (β2-MG)
timeFrame: before/after a single treatment session
measure: Serum indoxyl sulfate (IS)
timeFrame: before/after a single treatment session
measure: Serum p-cresyl sulfate (PCS)
timeFrame: before/after a single treatment session
measure: Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score
timeFrame: Week 0 to Week 24 (±7 days)
measure: Pruritus severity score
timeFrame: Week 0 to Week 24 (±7 days)
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 0 to Week 24 (±7 days)
measure: Hospitalization rate
timeFrame: Week 0 to Week 24 (±7 days)
measure: Mortality rate
timeFrame: Week 0 to Week 24 (±7 days)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: