Study of pHA Hemoperfusion Combined with Hemodialysis to Reduce Protein-Bound Toxins in Adults with End Stage Renal Disease

What this Trial Is About

Researchers are evaluating whether adding the pHA130 hemoperfusion device to standard hemodialysis HD or hemodiafiltration HDF helps remove protein-bound uremic toxins, specifically indoxyl sulfate IS and p-cresyl sulfate PCS, in patients with end-stage renal disease on maintenance dialysis. This single-center, prospective cohort study randomizes adults who have been on thrice-weekly, 4-hour HD for at least three months to one of three groups to compare toxin reduction over 24 weeks. Participants receive one of three treatment regimens HDHDF alone with HD twice weekly and HDF once weekly HDHDF combined with biweekly pHA130 hemoperfusion or HDHDF combined with biweekly HA130 hemoperfusion. Each dialysis session lasts 4 hours. The study includes a four-week washout period before measuring toxin levels at baseline and again at weeks 4, 12, and 24 to assess changes. Secondary measures include toxin removal per session, clearance of middle molecules, patient symptoms like itching and sleep quality, quality of life, hospitalization rates, and mortality. During the study, participants undergo regular blood tests to measure toxin levels and other markers before and after dialysis sessions. Researchers collect patient-reported outcomes on itching, sleep, and quality of life, and monitor safety through adverse event reporting and consistent anticoagulation dosing. The entire participation period covers 24 weeks, with assessments at specific intervals to understand the clinical value of adding hemoperfusion to conventional dialysis.

Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins