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Study identifier: NCT07016841 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

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

Condition: End Stage Renal Disease on Dialysis  ·  Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

PhaseN/A
Planned participants120
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Wei Lu  ·  8602125078999  ·  luwei03@xinhuamed.com.cn

Always discuss trial participation with your own doctor first.

Locations (1)

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of MedicineShanghai, Shanghai Municipality, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT07016841