Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins
Recruiting now
Conditions studied: End Stage Renal Disease on Dialysis
In brief
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.
Key facts
- Study ID
- NCT07016841
- Run by
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- People needed
- 120
- Starts
- 2025-05-12
- Expected to finish
- 2026-06-30
- Last updated by the study team
- 2025-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18 years, with no restriction on gender;
- Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
- Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
You may not qualify if…
- Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
- Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
- Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
- Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
- Patients with a platelet count < 60 × 10⁹/L;
- Other conditions deemed unsuitable for enrollment in this study by the researchers.
Where it is running
- Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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