Actively Recruiting
Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-06-12
120
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Receiving regular hemodialysis treatment 3 times per week, 4 hours per session
- Maintenance hemodialysis treatment for at least 3 months
- Willing and able to follow the study treatment protocol
- Signed informed consent form
You will not qualify if you...
- Receiving combined hemodialysis and peritoneal dialysis treatment
- Known allergy or intolerance to hemoperfusion device materials
- Acute severe infection
- Severe cardiopulmonary insufficiency
- Severe cerebrovascular disease
- Severe bleeding tendency or active bleeding
- Active malignant tumor or undergoing treatment for malignant tumors
- Platelet count less than 60 × 10⁹/L
- Other conditions that make participation unsuitable as determined by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200092
Actively Recruiting
Research Team
W
Wei Lu
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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