Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)
ConditionEnd Stage Renal Disease on Dialysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University People's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
pHA130 Hemoadsorption + High-Flux Hemodialysis
DeviceA 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).
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: 4-Hour HA GroupExperimental treatment 1 intervention
Group B: 2-Hour HA GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 visitSecondary outcomes
1
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 visit2
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)3
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)4
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 18Sponsors and contacts
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Source ClinicalTrials.gov