Actively Recruiting
Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study
Led by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-06-12
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding the pHA130 hemoperfusion device to standard hemodialysis (HD) or hemodiafiltration (HDF) helps remove protein-bound uremic toxins, specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS), in patients with end-stage renal disease on maintenance dialysis. This single-center, prospective cohort study randomizes adults who have been on thrice-weekly, 4-hour HD for at least three months to one of three groups to compare toxin reduction over 24 weeks. Participants receive one of three treatment regimens: HD/HDF alone with HD twice weekly and HDF once weekly; HD/HDF combined with biweekly pHA130 hemoperfusion; or HD/HDF combined with biweekly HA130 hemoperfusion. Each dialysis session lasts 4 hours. The study includes a four-week washout period before measuring toxin levels at baseline and again at weeks 4, 12, and 24 to assess changes. Secondary measures include toxin removal per session, clearance of middle molecules, patient symptoms like itching and sleep quality, quality of life, hospitalization rates, and mortality. During the study, participants undergo regular blood tests to measure toxin levels and other markers before and after dialysis sessions. Researchers collect patient-reported outcomes on itching, sleep, and quality of life, and monitor safety through adverse event reporting and consistent anticoagulation dosing. The entire participation period covers 24 weeks, with assessments at specific intervals to understand the clinical value of adding hemoperfusion to conventional dialysis.
CONDITIONS
Brief 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 three times per week, with each session lasting 4 hours
- Have been on maintenance hemodialysis treatment for at least 3 months
- Willing and able to follow the study treatment protocol
- Signed informed consent form for participation
You will not qualify if you...
- Receiving combined hemodialysis and peritoneal dialysis treatments
- Known allergy or intolerance to hemoperfusion device materials
- Acute severe infection, severe heart or lung failure, severe stroke, severe bleeding tendency, or active bleeding
- Active malignant tumors or undergoing treatment for cancer
- Platelet count below 60 x 10⁹/L
- Any other condition the researchers consider unsuitable for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive hemodialysis and hemodiafiltration treatments three times weekly, with each session lasting 4 hours. Some participants also receive hemoperfusion using either the pHA130 or HA130 hemoperfusion device once every 2 weeks, depending on the treatment group.
Approximately 72 treatment sessions over 24 weeks, including twice weekly hemodialysis and once weekly hemodiafiltration, with hemoperfusion sessions every 2 weeks as applicable
Duration - 24 weeks
Participants are monitored throughout the 24-week treatment period for various outcomes including serum toxin levels, quality of life, pruritus severity, sleep quality, hospitalization, and mortality rates.
Assessments before and after single treatment sessions and periodic evaluations during the 24-week period
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
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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