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

NCT07656168 | Recruiting

• 1 other identifier: 2025-KY-177-1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ESRD (End-Stage Renal Disease); Maintenance Hemodialysis

Keywords

Hemoadsorption; Protein-Bound Uremic Toxins; Indoxyl Sulfate; p-Cresyl Sulfate; Cardiovascular Events; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Reduction Ratio from baseline in Serum Indoxyl Sulfate (IS) and p-Cresol Sulfate (PCS) Concentration

  Percentage reduction in serum IS and PCS concentration from baseline after 12 months of treatment, measured by High-Performance Liquid Chromatography (HPLC).

  Baseline, 3, 6, 9, 12 Months

Secondary Outcomes (6)

• Change from baseline in Health-Related Quality of Life (HRQoL)

  Baseline, 3, 6, 9, 12 Months

• Change from baseline in Cognitive Function

  Baseline, 3, 6, 9, 12 Months

• Progression of Coronary Artery Calcification (CAC)

  Baseline, 6, 12 Months

• All-Cause Mortality

  Up to 12 Months

• Incidence of Major Adverse Cardiovascular Events (MACEs)

  Up to 12 Months

Study Arms (2)

HAHD Group

EXPERIMENTAL

Participants assigned to this group will receive a combination of hemodialysis (HD) and hemoadsorption (HA) therapy.

Device: pHA130 Hemoadsorption Cartridge

HD Group

ACTIVE COMPARATOR

Participants assigned to this group will receive standard maintenance hemodialysis therapy.

Device: High-flux Hemodialyzer

Interventions

pHA130 Hemoadsorption Cartridge DEVICE

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.

HAHD Group

High-flux Hemodialyzer DEVICE

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

HD Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Known allergy to the dialyzer or hemoperfusion device.
• Platelet count \< 60×10⁹/L.
• Serum albumin \< 30 g/L.
• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (1)

China-Japan Friendship Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wenge Li, MD

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Lu, PhD

CONTACT

+8619834515101; lujiandr@163.com

Shimin Jiang, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: June 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)