RecruitingNot ApplicableNCT07111260

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Comparison of the Efficacy of Hemoadsorption Combined With Hemodialysis of Different Treatment Durations in Clearing Protein-Bound Uremic Toxins: A Randomized Crossover Controlled Trial

Sponsor

Peking University People's Hospital

Enrollment

34 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

End Stage Renal Disease on Dialysis

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria8

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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Interventions

DEVICEpHA130 Hemoadsorption + High-Flux Hemodialysis

A combination blood-purification procedure in which a pHA130 hemoperfusion cartridge is connected in series with a high-flux hemodialyzer. Blood first passes through the HP cartridge to adsorb protein-bound uremic toxins and is then dialyzed. In the 4-hour arm the HP cartridge remains online for the entire 4-hour session; in the 2-hour arm the cartridge is removed after 2 hours and dialysis continues alone for the remaining 2 hours. Blood-flow rates are 250-350 mL/min (4-hour arm) or 200-250 mL/min (2-hour arm).