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

June 10, 2025 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Effects of Conventional Hemodialysis Combined With pHA Hemoperfusion Therapy on Protein-Bound Uremic Toxins in Maintenance Hemodialysis Patients: A Single-Center, Prospective Cohort Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
HP once every 2 weeks.
Device: HD/HDF
HD twice weekly, HDF once weekly, with each session lasting 4 hours.
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
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.
Device: HD/HDF
HD twice weekly, HDF once weekly, with each session lasting 4 hours.
Device: HA130 hemoperfusion device
HP once every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum indoxyl sulfate (IS)
Time Frame: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
Week 0 to Week 24 (±7 days)
Serum p-cresyl sulfate (PCS)
Time Frame: Week 0 to Week 24 (±7 days)
value at 24 weeks minus value at baseline reported
Week 0 to Week 24 (±7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parathyroid hormone (PTH)
Time Frame: before/after a single treatment session
Reduction rate of parathyroid hormone (PTH) before/after a single treatment session
before/after a single treatment session
β2-microglobulin (β2-MG)
Time Frame: before/after a single treatment session
Reduction rate of β2-microglobulin (β2-MG) before/after a single treatment session.
before/after a single treatment session
Serum indoxyl sulfate (IS)
Time Frame: before/after a single treatment session
Reduction rate of serum indoxyl sulfate (IS) before/after a single treatment session
before/after a single treatment session
Serum p-cresyl sulfate (PCS)
Time Frame: before/after a single treatment session
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
Time Frame: 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.
Week 0 to Week 24 (±7 days)
Pruritus severity score
Time Frame: Week 0 to Week 24 (±7 days)
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)
Time Frame: Week 0 to Week 24 (±7 days)
Change in Pittsburgh Sleep Quality Index (PSQI) from baseline to Week 24
Week 0 to Week 24 (±7 days)
Hospitalization rate
Time Frame: 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)
Week 0 to Week 24 (±7 days)
Mortality rate
Time Frame: Week 0 to Week 24 (±7 days)
24-week-mortality (All-cause, cardiovascular event, infection, vascular access event-related and β2-MG-related symptom )
Week 0 to Week 24 (±7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

May 26, 2025

First Submitted That Met QC Criteria

June 10, 2025

First Posted (Actual)

June 12, 2025

Study Record Updates

Last Update Posted (Actual)

June 12, 2025

Last Update Submitted That Met QC Criteria

June 10, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-25-005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease on Dialysis

Clinical Trials on pHA130 hemoperfusion device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe