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Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

RecruitingNAAges 18 Years - 75 YearsAllPeking University People's Hospital
NCT07111260 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age between 18 and 75 years, regardless of gender * Stable maintenance hemodialysis for ≥3 months, with a relatively fixed dialysis regimen * Receiving hemodialysis 3 times per week, each session lasting ≥4 hours * Single-pool Kt/V (spKt/V) ≥1.2 within 8 weeks prior to enrollment * Willing and able to sign the informed consent form Exclusion Criteria: * Life expectancy less than 1 year * White blood cell count \< 4 × 10⁹/L and/or platelet count \< 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
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What it tests

  • pHA130 Hemoadsorption + High-Flux Hemodialysis
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Where

1 site
Peking University People's Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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