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

NCT07016841 | Recruiting DMC

• 1 other identifier: XH-25-005
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Hemoadsorption; Hemodialysis

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (9)

• Parathyroid hormone (PTH)

  before/after a single treatment session

• β2-microglobulin (β2-MG)

  before/after a single treatment session

• Serum indoxyl sulfate (IS)

  before/after a single treatment session

• 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)

Study Arms (3)

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.

Device: pHA130 hemoperfusion device; Device: HD/HDF

control group 1

Control Group 1: HD/HDF Treatment regimen: HD twice weekly, HDF once weekly, with each session lasting 4 hours.

Device: HD/HDF

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.

Device: HD/HDF; Device: HA130 hemoperfusion device

Interventions

pHA130 hemoperfusion device DEVICE

HP once every 2 weeks.

experimental group

HD/HDF DEVICE

HD twice weekly, HDF once weekly, with each session lasting 4 hours.

control group 1; control group 2; experimental group

HA130 hemoperfusion device DEVICE

HP once every 2 weeks.

control group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stable maintenance hemodialysis patients meeting the inclusion and exclusion criteria with a dialysis vintage ≥3 months.

You may qualify if:

• Age ≥18 years, with no restriction on gender;
• Undergoing regular hemodialysis 3 times per week, 4 hours per session, and has received maintenance hemodialysis treatment for ≥3 months;
• Willing and able to receive treatment as per the protocol requirements, and has signed the informed consent form for subjects.

You may not qualify if:

• Patients receiving combined hemodialysis (HD) and peritoneal dialysis (PD) treatment;
• Patients with known allergy to hemoperfusion device materials, contraindications, or intolerance to the device;
• Patients with acute severe infection, severe cardiopulmonary insufficiency, severe cerebrovascular disease, severe bleeding tendency, or active bleeding;
• Patients with malignant tumors in the active stage or undergoing treatment for malignant tumors;
• Patients with a platelet count \< 60 × 10⁹/L;
• Other conditions deemed unsuitable for enrollment in this study by the researchers.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Central Study Contacts

Wei Lu

CONTACT

8602125078999; luwei03@xinhuamed.com.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 12, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 12, 2025

Record last verified: 2024-12

Locations

CN (1)