Study Comparing 2-Hour Versus 4-Hour Hemoadsorption Combined With Hemodialysis for Removing Protein-Bound Uremic Toxins in Patients With End-Stage Renal Disease

What this Trial Is About

Researchers are investigating the effectiveness of extending hemoadsorption HA treatment duration from 2 hours to 4 hours combined with hemodialysis HD in patients with end-stage renal disease ESRD on maintenance hemodialysis. This study focuses on clearing protein-bound uremic toxins such as Indoxyl Sulfate IS and p-Cresyl Sulfate PCS, which are linked to higher cardiovascular risks and are not well removed by standard dialysis. The trial is designed as an open-label, randomized, crossover study to provide clear evidence on optimizing HA treatment time. Participants will receive high-flux hemodialysis twice weekly and hemoadsorption combined with hemodialysis once weekly. They will be randomly assigned to either a 2-hour HA session or a 4-hour HA session using a pHA130 cartridge. In the 4-hour group, the cartridge remains active throughout the dialysis session, while in the 2-hour group, the cartridge is removed after 2 hours, and dialysis continues alone. After 8 weeks on one treatment, participants cross over to the other treatment following a 2-week washout period, allowing comparison within the same individuals. During the study, blood samples will be collected at multiple time points to measure reductions in IS and PCS levels. Researchers will monitor toxin clearance rates, changes in pre-dialysis toxin levels, and any adverse events or changes in vital signs throughout the 18-week study period. This will help assess both the efficacy and safety of the extended hemoadsorption duration for improving toxin removal in ESRD patients on dialysis.

Efficacy of pHA130 Hemoadsorption for 4 Hours (p4H Study)