Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: pHA130 Hemoadsorption + High-Flux Hemodialysis.
- Who it may be relevant to
- Registry conditions: End Stage Renal Disease on Dialysis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Detailed 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.
Interventions
- Device pHA130 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/
Primary outcome measures
- Reduction Rate of Serum Indoxyl Sulfate (IS) [Time frame: At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit]
Secondary outcome measures (5)
- Reduction Rate of p-Cresyl Sulfate (PCS) [Time frame: At Week 1, Week 8, Week 11, and Week 18; blood samples will be collected at 0 hours (before treatment), 2 hours after treatment begins, and 4 hours (end of treatment) during each visit]
- Change from Baseline in Pre-dialysis IS levels [Time frame: Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)]
- Change from Baseline in Pre-dialysis PCS levels [Time frame: Baseline (Week 1) to end of period 1 (Week 8); Baseline of period 2 (Week 11) to end of period 2 (Week 18)]
- Clearance of Other Uremic Toxins [Time frame: Week 1, Week 8, Week 11, Week 18]
- Number of Participants With Adverse Events, Circuit Coagulation, and Abnormal Changes in Vital Signs or Laboratory Parameters [Time frame: Throughout the entire study duration (up to 18 weeks)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT07111260 · 2025PHB095-001