Actively Recruiting
Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)
Led by Peking University People's Hospital · Updated on 2025-08-08
34
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, randomized, crossover study to evaluate the efficacy of extending the duration of hemoadsorption (HA) combined with hemodialysis (HD) from 2 hours to 4 hours for clearing protein-bound uremic toxins, such as Indoxyl Sulfate (IS), in stable maintenance hemodialysis patients. Patients will be randomized to receive either 2-hour HA or 4-hour HA once a week for 8 weeks, then cross over to the other treatment for another 8 weeks after a 2-week washout period. The primary endpoint is the reduction rate of IS.
CONDITIONS
Official 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 fixed dialysis regimen
- Receiving hemodialysis 3 times per week, each session lasting at least 4 hours
- Single-pool Kt/V of 1.2 or higher 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 �d7 10�b9/L and/or platelet count less than 60 �d7 10�b9/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
- Deemed unsuitable for the study by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
L
Liangying Gan
CONTACT
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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