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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-12

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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End Stage Renal Disease on Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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experimental group

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.

pHA130 hemoperfusion device

Intervention Type DEVICE

HP once every 2 weeks.

HD/HDF

Intervention Type DEVICE

HD twice weekly, HDF once weekly, with each session lasting 4 hours.

control group 1

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

HD/HDF

Intervention Type DEVICE

HD twice weekly, HDF once weekly, with each session lasting 4 hours.

control group 2

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.

HD/HDF

Intervention Type DEVICE

HD twice weekly, HDF once weekly, with each session lasting 4 hours.

HA130 hemoperfusion device

Intervention Type DEVICE

HP once every 2 weeks.

Interventions

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pHA130 hemoperfusion device

HP once every 2 weeks.

Intervention Type DEVICE

HD/HDF

HD twice weekly, HDF once weekly, with each session lasting 4 hours.

Intervention Type DEVICE

HA130 hemoperfusion device

HP once every 2 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No