Actively Recruiting
Comparison of Hemoadsorption Combined With Hemodialysis for 2 Hours Versus 4 Hours to Clear Protein-Bound Uremic Toxins in End Stage Renal Disease: A Randomized Crossover Trial
Led by Peking University People's Hospital · Updated on 2025-08-08
34
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness of extending hemoadsorption (HA) treatment duration from 2 hours to 4 hours combined with hemodialysis (HD) in patients with end-stage renal disease (ESRD) on maintenance hemodialysis. This study focuses on clearing protein-bound uremic toxins such as Indoxyl Sulfate (IS) and p-Cresyl Sulfate (PCS), which are linked to higher cardiovascular risks and are not well removed by standard dialysis. The trial is designed as an open-label, randomized, crossover study to provide clear evidence on optimizing HA treatment time. Participants will receive high-flux hemodialysis twice weekly and hemoadsorption combined with hemodialysis once weekly. They will be randomly assigned to either a 2-hour HA session or a 4-hour HA session using a pHA130 cartridge. In the 4-hour group, the cartridge remains active throughout the dialysis session, while in the 2-hour group, the cartridge is removed after 2 hours, and dialysis continues alone. After 8 weeks on one treatment, participants cross over to the other treatment following a 2-week washout period, allowing comparison within the same individuals. During the study, blood samples will be collected at multiple time points to measure reductions in IS and PCS levels. Researchers will monitor toxin clearance rates, changes in pre-dialysis toxin levels, and any adverse events or changes in vital signs throughout the 18-week study period. This will help assess both the efficacy and safety of the extended hemoadsorption duration for improving toxin removal in ESRD patients on dialysis.
CONDITIONS
Brief Title
Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, regardless of gender
- Stable maintenance hemodialysis for at least 3 months with a relatively fixed dialysis regimen
- Receiving hemodialysis 3 times per week, each session lasting 4 hours or more
- Single-pool Kt/V of at least 1.2 within 8 weeks prior to enrollment
- Willing and able to sign the informed consent form
You will not qualify if you...
- Life expectancy less than 1 year
- White blood cell count less than 4 × 10⁹/L and/or platelet count less than 60 × 10⁹/L
- Active or chronic gastrointestinal bleeding, or diagnosed coagulation disorders
- Active malignant tumor
- Active infection
- Pregnant or breastfeeding
- Participation in another clinical trial within the past month or currently enrolled in one
- Deemed unsuitable for the study by the investigator
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 - Up to 18 weeks
Participants receive hemoadsorption combined with high-flux hemodialysis either for 2 hours or 4 hours in a randomized crossover design to compare toxin clearance effectiveness.
Weekly hemoadsorption combined with hemodialysis sessions
Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Liangying Gan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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