Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure

NCT07656168 · tracked via the Priya Life Science China tracker

Sponsor

China-Japan Friendship Hospital

Phase

Not applicable

Started

2026-06-01

Last updated

2026-06-25

Condition(s) studied

ESRD (End-Stage Renal Disease)Maintenance Hemodialysis

Investigational drug(s) / intervention(s)

pHA130 Hemoadsorption CartridgeHigh-flux Hemodialyzer

pHA130 Hemoadsorption Cartridge: Following a 4-week run-in period,patients receive High-flux hemodialysis (HD) twice a week and combined HAHD once a week. During the HAHD session, the pHA130 hemoadsorption cartridge is placed in series with a high-flux dialyzer. Each treatment session lasts for 4 hours.

High-flux Hemodialyzer: Patients receive conventional high-flux hemodialysis (HD) three times a week. Each treatment session lasts for 4 hours.

Study summary

Patients on maintenance hemodialysis (MHD) face a high risk of cardiovascular mortality and reduced quality of life. Conventional high-flux hemodialysis (HD) is the standard of care but has limited efficacy in clearing middle-molecular and protein-bound uremic toxins (PBUTs). The accumulation of these toxins is associated with adverse long-term outcomes.

This study evaluates the efficacy and safety of the pHA130 hemoadsorption cartridge, which utilizes a modified resin for enhanced PBUT adsorption, when combined with hemodialysis (HAHD). This is a prospective, open-label, multi-center, randomized controlled trial involving 100 MHD patients. Participants will be randomized 1:1 to either the HAHD group (receiving one HAHD session using the pHA130 cartridge and two standard HD sessions weekly) or the Control group (receiving three standard HD sessions weekly).

The primary objective is to assess the reduction in serum indoxyl sulfate (IS) and p-cresol sulfate (PCS) levels from baseline to 12 months. Secondary objectives include evaluating changes in quality of life (KDQoL-SF, MMSE), the progression of coronary artery calcification (CAC), the incidence of major adverse cardiovascular events (MACEs), all-cause mortality, and safety profiles. This trial aims to determine if integrating long-term HAHD therapy can optimize blood purification strategies for the MHD population.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age \> 18 years. * On maintenance hemodialysis for \> 3 months. * Receiving hemodialysis 3 times per week, 4 hours per session. * Standard Kt/V ≥ 1.2. * Voluntarily participates and provides written informed consent. Exclusion Criteria: * Known allergy to the dialyzer or hemoperfusion device. * Platelet count \< 60×10⁹/L. * Serum albumin \< 30 g/L. * 24-hour urine output \> 200 ml. * Inability to achieve a blood flow rate ≥ 200 ml/min. * Coagulation disorders, severe bleeding tendency, or active bleeding. * Pre-dialysis systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg. * Active malignancy. * Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems. * Planned living-donor kidney transplant within the next 6 months. * Current participation in another interventional clinical study, or participation within the past 3 months in an interventional study that may interfere with the present study (e.g., fecal microbiota transplantation); or use of intestinal microecological regulators such as probiotics. * History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.

Primary outcome measure(s)

Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration — Baseline, 3, 6, 9, 12 Months
Percentage reduction in serum IS and PCS concentration from baseline after 12 months of treatment, measured by High-Performance Liquid Chromatography (HPLC).

Trial sites (1)

Facility	City	Region	Status
China-Japan Friendship Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07656168 on ClinicalTrials.gov ↗ ← All trials in China