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

Shanghai Jiao Tong University

Status: Enrolling

Conditions: End Stage Renal Disease on Dialysis

Treatments: Device: HD/HDF; Device: HA130 hemoperfusion device; Device: pHA130 hemoperfusion device

Study type: Observational

Funder types: Other

Identifiers

NCT07016841

XH-25-005

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 3 patient groups

experimental group

Description:

Treatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.

Treatment:

Device: pHA130 hemoperfusion device

Device: HD/HDF

control group 1

Description:

Control Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours.

Treatment:

Device: HD/HDF

control group 2

Description:

Control Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks.

Treatment:

Device: HA130 hemoperfusion device

Device: HD/HDF