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Clinical Trial

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

NCT: NCT07016841 · COMPLETED

NCT IDNCT07016841
StatusCOMPLETED
Start Date2025-05-12
Completion2026-06-30
SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine (OTHER)
First posted
Last updated

Brief Summary

This single-center, prospective cohort Study evaluates whether adding the pHA130 hemoperfusion cartridge to conventional hemodialysis (HD) or hemodiafiltration (HDF) more effectively reduces protein-bound uremic toxins-specifically indoxyl sulfate (IS) and p-cresyl sulfate (PCS)-in maintenance HD patients. Adults on thrice-weekly, 4-hour HD for at least three months are randomized to one of three arms: HD/HDF alone; HD/HDF plus biweekly pHA130 hemoperfusion; or HD/HDF plus biweekly HA130 hemoperfusion. After a four-week washout, toxin levels are measured at baseline and again at Weeks 4, 12, and 24, with the primary endpoint being the reduction in IS and PCS at Week 24. Secondary endpoints include single-session toxin removal, middle-molecule clearance (β₂-microglobulin, PTH), patient-reported outcomes (itching, sleep, quality of life), and rates of hospitalization and mortality. Safety is closely monitored through adverse event reporting and consistent anticoagulation dosing. Findings will clarify the clinical value of pHA130 hemoperfusion for improving toxin clearance and guiding optimal dialysis strategies.

Frequently Asked Questions

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

Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins is a clinical trial registered under NCT07016841. Current status: COMPLETED.

What is the status of NCT07016841?

The current status of NCT07016841 (Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins) is: COMPLETED.

When did Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins start?

Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins started on 2025-05-12.

Official Source

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Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.