Evaluating the pHA130 Hemoadsorption Cartridge Combined with Hemodialysis Versus Standard High-Flux Hemodialysis for Removing Protein-Bound Toxins and Improving Quality of Life in Kidney Failure

What this Trial Is About

Patients with end-stage renal disease ESRD undergoing maintenance hemodialysis MHD face a high risk of cardiovascular death and reduced quality of life due to the buildup of protein-bound uremic toxins PBUTs like indoxyl sulfate IS and p-cresol sulfate PCS. Conventional high-flux hemodialysis HD clears small toxins but is limited in removing these PBUTs, which are linked to vascular calcification and serious symptoms. This trial evaluates whether adding a new device, the pHA130 hemoadsorption cartridge, to HD can better reduce these harmful toxins and improve patient outcomes. The study randomly assigns 100 patients to two groups after a 4-week run-in period. One group receives a combination of hemoadsorption with hemodialysis HAHD once a week using the pHA130 cartridge plus two standard HD sessions weekly. The other group receives standard high-flux HD three times a week. Each dialysis or HAHD session lasts about 4 hours. The pHA130 cartridge uses a special resin designed to enhance removal of PBUTs by electrostatic and molecular mechanisms. Participants are followed for 12 months with regular assessments of serum toxin levels IS and PCS, quality of life, cognitive function, coronary artery calcification, cardiovascular events, and safety. Evaluations occur at baseline and at 3, 6, 9, and 12 months. This study aims to provide new evidence on whether integrating HAHD therapy optimizes blood purification and long-term health for people on maintenance hemodialysis.

Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure