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NCT Number: NCT07016841

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

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.

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Key information

Conditions

End Stage Renal Disease on Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

pHA130 hemoperfusion device

Device

HP once every 2 weeks.

HD/HDF

Device

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

HA130 hemoperfusion device

Device

HP once every 2 weeks.

Primary outcomes

  1. Serum indoxyl sulfate (IS)

    Time frame: Week 0 to Week 24 (±7 days)

    value at 24 weeks minus value at baseline reported

  2. Serum p-cresyl sulfate (PCS)

    Time frame: Week 0 to Week 24 (±7 days)

    value at 24 weeks minus value at baseline reported

Secondary outcomes

  1. Parathyroid hormone (PTH)

    Time frame: before/after a single treatment session

    Reduction rate of parathyroid hormone (PTH) before/after a single treatment session

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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)

  9. 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 )

Study contacts

Contact information is provided by the study sponsor or research team.

Wei Lu

CONTACT

[email protected]

8602125078999

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 12, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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