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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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