Study on KHA80 Hemoperfusion with Hemodialysis Versus Routine Hemodialysis in Maintaining Blood Clearance of IL-6, β2-MG, and PTH in Hemodialysis Patients

What this Trial Is About

Researchers are studying patients with uremia, uremic osteodystrophy, and dialysis-related complications to evaluate the reduction in blood levels of IL-6, beta-2 microglobulin, and parathyroid hormone over 52 weeks. The study compares the effects of a new blood purification device, KHA80 hemoperfusion, combined with routine hemodialysis treatments. This is a prospective, multicenter, randomized, open-label study involving patients receiving maintenance hemodialysis. The study includes 394 patients who undergo at least 8 hours of blood purification per week, including routine hemodialysis, high-throughput hemodialysis, hemodiafiltration, or hemoperfusion. Participants are randomly assigned to either a control group receiving hemodialysis or hemodiafiltration at least twice a week, or an experimental group receiving KHA80 hemoperfusion treatment at least twice a month in addition to their hemodialysis or hemodiafiltration treatments. Data and safety information are collected at baseline and at 4, 12, 24, 36, and 52 weeks. Participants have their blood levels of IL-6, beta-2 microglobulin, and parathyroid hormone measured throughout the study to assess changes. Researchers also record combined medication use and monitor for adverse events. The main outcome measure is the rate of change in these blood markers at the 52nd week. The study aims to provide information on the safety and effectiveness of adding KHA80 hemoperfusion to standard dialysis treatments in maintenance hemodialysis patients.

Multi-center Clinical Study on Hemoperfusion of KHA80