An interventional study of pHA130 Hemoadsorption + High-Flux Hemodialysis in End Stage Renal Disease on Dialysis, sponsored by Peking University People's Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by Peking University People's Hospital · Not applicable, Interventional, and Treatment
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.
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.
Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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Exclusion Criteria:
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.
Device: pHA130 Hemoadsorption + High-Flux Hemodialysis
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.
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/min (2-hour arm).
Reduction Rate of Serum Indoxyl Sulfate (IS)
The reduction rate (RR) of serum Indoxyl Sulfate (IS) after a single HAHD treatment session. The RR is calculated as: RR(%) = (1 - (Post-treatment Concentration / Pre-treatment Concentration)) × 100. Post-treatment concentration will be corrected for hemoconcentration.
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
Reduction Rate of p-Cresyl Sulfate (PCS)
RR of serum PCS after a single session
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
Change in pre-dialysis serum concentrations of IS from the beginning to the end of each 8-week treatment period
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
Change in pre-dialysis serum concentrations of PCS from the beginning to the end of each 8-week treatment period
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
Reduction rates and/or clearance of urea, creatinine, β2-microglobulin, C-reactive protein (CRP), and Interleukin-6 (IL-6)
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
All adverse events (AEs) reported during the study will be recorded and assessed for severity and relationship to the intervention. Specific safety indicators include the incidence of circuit coagulation, decreases in white blood cell count, platelet count, and hemoglobin levels, as well as changes in vital signs.
Time frame: Throughout the entire study duration (up to 18 weeks)
Plan to share: No
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Peking University People's Hospital