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NCT07016841

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

Recruiting now Last updated 12 June 2025
What this trial tests

trial testing pHA130 hemoperfusion device in End Stage Renal Disease on Dialysis in 120 participants. Currently enrolling.

Timeline
12 May 2025
Primary endpoint
30 June 2026
30 June 2026

Quick facts

Lead sponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment120
Start date12 May 2025
Primary completion30 June 2026
Estimated completion30 June 2026
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

18 and older, any sex, with End Stage Renal Disease on Dialysis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for End Stage Renal Disease on Dialysis

Currently open trials in the same condition.

Other Xinhua Hospital, Shanghai Jiao Tong University School of Medicine trials

Trials by the same sponsor.

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Data sources for this page

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