NCT07111260 Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)
| NCT ID | NCT07111260 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | End Stage Renal Disease on Dialysis |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-07-01 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 34 participants in total. It began in 2025-07-01 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Li Zuo
PRINCIPAL INVESTIGATOR
Renal Division, Department of Medicine, Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07111260 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying End Stage Renal Disease on Dialysis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07111260 currently recruiting?
Yes, NCT07111260 is actively recruiting participants. Contact the research team at ganl@bjmu.edu.cn for enrollment information.
Where is the NCT07111260 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07111260 clinical trial?
NCT07111260 is sponsored by Peking University People's Hospital. The principal investigator is Li Zuo at Renal Division, Department of Medicine, Peking University People's Hospital. The trial plans to enroll 34 participants.