Adding pHA hemoperfusion to hemodialysis to lower protein-bound uremic toxins

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

This trial tests whether adding a pHA130 blood‑filter to regular hemodialysis helps adults on maintenance dialysis remove protein‑bound toxins like indoxyl sulfate and p‑cresyl sulfate.

Quick facts

• Study type: Observational
• Enrollment: 120 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (Academic / other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07016841 on ClinicalTrials.gov

What this trial studies

This is a single‑center, prospective randomized cohort at Xinhua Hospital comparing three approaches: conventional hemodialysis/hemodiafiltration (HD/HDF) alone, HD/HDF plus biweekly pHA130 hemoperfusion, and HD/HDF plus biweekly HA130 hemoperfusion. After a four‑week washout, blood levels of protein‑bound toxins (indoxyl sulfate and p‑cresyl sulfate) are measured at baseline and at Weeks 4, 12, and 24, with the primary endpoint being toxin reduction at Week 24. Secondary endpoints include single‑session toxin removal, middle‑molecule clearance (β2‑microglobulin, PTH), patient‑reported symptoms (itching, sleep, quality of life), and rates of hospitalization and death. Safety is monitored through adverse event reporting and standardized anticoagulation dosing.

Who should consider this trial

Good fit: Adults aged 18 or older who have been on thrice‑weekly, 4‑hour maintenance hemodialysis for at least three months and can follow the protocol are the intended participants.

Not a fit: People on combined HD and peritoneal dialysis, with active severe infections, advanced cardiopulmonary or cerebrovascular disease, active cancer treatment, significant bleeding risks or very low platelets, or known allergy to the device materials are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, adding hemoperfusion could lower levels of protein‑bound toxins and may relieve toxin‑related symptoms or reduce complications for people on maintenance dialysis.

How similar studies have performed: Previous small studies and adsorbent technologies have shown some reduction in protein‑bound toxin levels, but robust evidence that this improves clinical outcomes remains limited.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Wei Lu

Conditions End Stage Renal Disease on Dialysis; Hemoadsorption; Hemodialysis