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NCT07016841
Effects of pHA Hemoperfusion Plus Hemodialysis on Protein-Bound Uremic Toxins
trial testing pHA130 hemoperfusion device in End Stage Renal Disease on Dialysis in 120 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 12 May 2025 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- pHA130 hemoperfusion device
- HD/HDF
- HA130 hemoperfusion device
Conditions studied
- End Stage Renal Disease on Dialysis — all drugs for End Stage Renal Disease on Dialysis →
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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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07016841 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Last refreshed: 12 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07016841.
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