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

Launched by XINHUA HOSPITAL, SHANGHAI JIAO TONG UNIVERSITY SCHOOL OF MEDICINE · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a special treatment called pHA130 hemoperfusion to regular hemodialysis (a common treatment for kidney failure) can help remove harmful substances from the blood more effectively. These harmful substances, known as protein-bound uremic toxins, can build up in patients with end-stage renal disease. The trial involves adults who have been on hemodialysis three times a week for at least three months. Participants will be placed into one of three groups: one receiving only hemodialysis, another receiving hemodialysis plus pHA130 hemoperfusion, and the last one receiving hemodialysis plus a different type of pHA130 treatment.

To be eligible for the study, participants must be at least 18 years old and have been on hemodialysis for a minimum of three months. They should not have certain health issues, like severe infections or active cancer, and they must be able to follow the study's treatment plan. Throughout the study, researchers will monitor participants' health closely and measure the levels of toxins in their blood at different times. This research aims to find out if the added treatment can improve the effectiveness of dialysis and enhance patients' quality of life by reducing symptoms like itching and improving overall well-being.

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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.