End Stage Renal Disease on Dialysis
Conditions
Keywords
Hemoadsorption, Hemodialysis
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.
Interventions
DEVICEpHA130 hemoperfusion device
HP once every 2 weeks.
DEVICEHD/HDF
HD twice weekly, HDF once weekly, with each session lasting 4 hours.
DEVICEHA130 hemoperfusion device
HP once every 2 weeks.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years, with no restriction on gender; 2. Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months; 3. Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.
Exclusion criteria
1. Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment; 2. Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device; 3. Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding; 4. Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors; 5. Patients with a platelet count \< 60 × 10⁹/L; 6. Other conditions deemed unsuitable for enrollment in this study by the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum indoxyl sulfate (IS) | Week 0 to Week 24 (±7 days) | value at 24 weeks minus value at baseline reported |
| Serum p-cresyl sulfate (PCS) | Week 0 to Week 24 (±7 days) | value at 24 weeks minus value at baseline reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parathyroid hormone (PTH) | before/after a single treatment session | Reduction rate of parathyroid hormone (PTH) before/after a single treatment session |
| β2-microglobulin (β2-MG) | before/after a single treatment session | Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session. |
| Serum indoxyl sulfate (IS) | before/after a single treatment session | Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session |
| Serum p-cresyl sulfate (PCS) | before/after a single treatment session | Reduction rate of serum p-cresyl sulfate (PCS) before/after a single treatment session. |
| Kidney Disease Quality of Life Short Form (KDQOL-SF) Total Score | Week 0 to Week 24 (±7 days) | Change in KDQOL-SF (Kidney Disease Quality of Life Short Form) total score from baseline to week 24. |
| Pruritus severity score | Week 0 to Week 24 (±7 days) | Change from baseline in pruritus severity score (VAS and Modified Duo Pruritus Score) at Week 24. |
| Pittsburgh Sleep Quality Index (PSQI) | Week 0 to Week 24 (±7 days) | Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 24 |
| Hospitalization rate | Week 0 to Week 24 (±7 days) | 24-week hospitalization rate (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom hospitalization rate) |
| Mortality rate | Week 0 to Week 24 (±7 days) | 24-week-mortality (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom ) |
Countries
China
Outcome results
None listed