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

Recruiting

• Conditions: End Stage Renal Disease on Dialysis

• Registration Number: NCT07016841
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2025-05-12
• Study First Submitted: 2025-05-26
• Study First Submitted QC: 2025-06-10
• Last Update Submitted: 2025-06-10
• Study First Posted: 2025-06-12
• Last Update Posted: 2025-06-12
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 )
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.

Trial Locations

Locations (1)

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China