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

ConditionsESRD (End-Stage Renal Disease)Maintenance Hemodialysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChina-Japan Friendship Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18 years.

On maintenance hemodialysis for > 3 months.

Receiving hemodialysis 3 times per week, 4 hours per session.

Standard Kt/V ≥ 1.2.

Disqualifiers

Known allergy to the dialyzer or hemoperfusion device.

Platelet count < 60×10⁹/L.

Serum albumin < 30 g/L.

24-hour urine output > 200 ml.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • High-flux Hemodialyzer

    Device

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: HAHD GroupExperimental treatment 1 intervention
Group B: HD GroupActive comparator 1 intervention

Trial outcomes

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).

Time frame
Baseline, 3, 6, 9, 12 Months

Secondary outcomes

1

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

Health-Related Quality of Life (HRQoL) is assessed using the Kidney Disease Quality of Life Short Form (KDQOL-SF). The KDQOL-SF scores range from a minimum of 0 to a maximum of 100. A higher score indicates a better health-related quality of life.

Time frame
Baseline, 3, 6, 9, 12 Months
2

Change from baseline in Cognitive Function

Cognitive function is assessed using the Mini-Mental State Examination (MMSE). The MMSE total score ranges from a minimum of 0 to a maximum of 30. A lower score indicates more severe cognitive impairment (i.e., a higher score reflects better cognitive function).

Time frame
Baseline, 3, 6, 9, 12 Months
3

Progression of Coronary Artery Calcification (CAC)

Coronary Artery Calcification (CAC) progression is assessed by measuring the change in the Agatston score using Computed Tomography (CT) scans. The Agatston score has a minimum value of 0, with no defined maximum upper limit. A higher score indicates a greater burden of coronary artery calcification and a higher cardiovascular risk.

Time frame
Baseline, 6, 12 Months
4

All-Cause Mortality

Number of deaths from any cause during the study period.

Time frame
Up to 12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China-Japan Friendship Hospital

Lead sponsor

Zhuhai Hospital of Integrated Traditional Chinese and Western Medicine

Collaborator

Source ClinicalTrials.gov
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