Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)

Peking University

Status: Enrolling

Conditions: End Stage Renal Disease on Dialysis

Treatments: Device: pHA130 Hemoadsorption + High-Flux Hemodialysis

Study type: Interventional

Funder types: Other

Identifiers

NCT07111260

2025PHB095-001

Details and patient eligibility

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.

Full description

Patients with end-stage renal disease (ESRD) on maintenance hemodialysis (MHD) have a high burden of uremic toxins, particularly protein-bound uremic toxins (PBUTs), which are poorly cleared by conventional dialysis and are associated with high cardiovascular mortality. hemoadsorption (HA) is an adjunctive blood purification technique effective at removing PBUTs. The standard duration for HA sessions is typically 2-2.5 hours. However, emerging evidence suggests that extending the treatment duration may enhance toxin removal. This study aims to rigorously compare the efficacy and safety of a 4-hour HA session combined with hemodialysis against a standard 2-hour session in clearing key PBUTs like Indoxyl Sulfate (IS) and p-Cresyl Sulfate (PCS). The findings will provide crucial evidence for optimizing HA treatment protocols to improve toxin clearance and potentially patient outcomes in the ESRD population.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

4-Hour HA Group

Experimental group

Description:

Subjects receive high-flux hemodialysis (HFHD) twice a week and hemoadsorption combined with HFHD (HAHD) once a week. The HAHD session, using a pHA130 cartridge, lasts for the entire 4-hour duration of the dialysis session. Blood flow rate is maintained at 250-350 mL/min, consistent with the patient's original HD prescription.

Treatment:

Device: pHA130 Hemoadsorption + High-Flux Hemodialysis

2-Hour HA Group

Active Comparator group

Description:

Subjects receive high-flux hemodialysis (HFHD) twice a week and HAHD once a week. The hemoadsorption component, using a pHA130 cartridge, is performed for the first 2 hours of the session, after which the pHA130 cartridge is removed and the patient continues with standard HFHD for the remaining 2 hours. Blood flow rate during HA is 200-250 mL/min.

Treatment:

Device: pHA130 Hemoadsorption + High-Flux Hemodialysis