Four-hour pHA130 hemoadsorption with hemodialysis
Official title: Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial
Run by Peking University People's Hospital · NCT07111260 · Data updated 2026-11-12
We will test whether using pHA130 hemoadsorption for 4 hours instead of 2 during regular dialysis removes more protein-bound toxins like indoxyl sulfate in people on maintenance hemodialysis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | March 2026 |
| Study ends | May 2026 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT07111260 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 on stable thrice-weekly maintenance hemodialysis for at least 3 months, receiving sessions of at least 4 hours and with spKt/V ≥1.2, who can provide informed consent are ideal candidates.
✕Probably not a fit
Patients with life expectancy under one year, active infection or malignancy, significant bleeding or coagulation disorders, very low blood counts, pregnancy or breastfeeding, or those not on conventional thrice-weekly hemodialysis are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, randomized crossover study enrolls stable maintenance hemodialysis patients who will receive either 2-hour or 4-hour pHA130 hemoadsorption once weekly for 8 weeks, then switch to the alternate duration after a 2-week washout. The primary outcome is the reduction rate of indoxyl sulfate, with secondary interest in other protein-bound uremic toxins such as p-cresyl sulfate and safety measures. Treatments are given concomitantly with high-flux hemodialysis and participants are monitored for laboratory and clinical safety throughout. The crossover design lets each participant serve as their own control to compare toxin clearance between durations.
Why it matters
Potential benefit: If successful, longer hemoadsorption sessions could remove more harmful protein-bound toxins and potentially reduce related cardiovascular risk in dialysis patients.
How similar studies have gone: Smaller studies and pilot data show hemoadsorption can remove protein-bound toxins, but extended 4-hour sessions have not been widely tested and clinical benefits remain unproven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Peking University People's Hospital
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Principal investigator: Li Zuo — Renal Division, Department of Medicine, Peking University People's Hospital
- Study coordinator: Liangying Gan
- Email: ganl@bjmu.edu.cn
- Phone: 010-88324516
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.