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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Treatment regimen: Hemodialysis (HD)/Hemodiafiltration (HDF) combined with Hemoperfusion (HP) using the pHA130 hemoperfusion device, with HD administered twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. |
| |
| control group 1 | Control Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours. |
| |
| control group 2 | Control Group 2: HD/HDF combined with HP (HA130 hemoperfusion device) Treatment regimen: HD twice weekly, HDF once weekly (each session lasting 4 hours), and HP once every 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pHA130 hemoperfusion device | Device | HP once every 2 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serum indoxyl sulfate (IS) | value at 24 weeks minus value at baseline reported | Week 0 to Week 24 (±7 days) |
| Serum p-cresyl sulfate (PCS) | value at 24 weeks minus value at baseline reported | Week 0 to Week 24 (±7 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Parathyroid hormone (PTH) | Reduction rate of parathyroid hormone (PTH) before/after a single treatment session | before/after a single treatment session |
| β2-microglobulin (β2-MG) | Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session. |
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Inclusion Criteria:
Exclusion Criteria:
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Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei Lu | Contact | 8602125078999 | luwei03@xinhuamed.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200092 | China |
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| HD/HDF |
| Device |
HD twice weekly, HDF once weekly, with each session lasting 4 hours. |
|
| HA130 hemoperfusion device | Device | HP once every 2 weeks. |
|
| before/after a single treatment session |
| Serum indoxyl sulfate (IS) | Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session | before/after a single treatment session |
| Serum p-cresyl sulfate (PCS) | Reduction rate of serum p-cresyl sulfate (PCS) before/after a single treatment session. | before/after a single treatment session |
| Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score | Change in KDQOL-SF (Kidney Disease Quality of Life Short Form) total score from baseline to week 24. | Week 0 to Week 24 (±7 days) |
| Pruritus severity score | Change from baseline in pruritus severity score (VAS and Modified Duo Pruritus Score) at Week 24. | Week 0 to Week 24 (±7 days) |
| Pittsburgh Sleep Quality Index (PSQI) | Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 24 | Week 0 to Week 24 (±7 days) |
| Hospitalization rate | 24-week hospitalization rate (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom hospitalization rate) | Week 0 to Week 24 (±7 days) |
| Mortality rate | 24-week-mortality (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom ) | Week 0 to Week 24 (±7 days) |