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
Qualifiers
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
Treatments tested in this trial
- pHA130 Hemoadsorption + High-Flux Hemodialysis
Treatment groups
34 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov