RecruitingNot Applicable

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

China100 participantsStarted 2026-06-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is testing a device called pHA130 that's added on to regular hemodialysis to try to remove specific toxins called indoxyl sulfate and p-cresol sulfate — can you explain whether my current dialysis sessions are effectively clearing these toxins, and whether that's something we should even be concerned about in my case?
2Since this trial hasn't started recruiting yet, how long might it realistically be before I could even consider joining, and should we be making treatment decisions now rather than waiting?
3The trial is listed as Phase NA, which suggests it may be studying a device rather than a drug — can you help me understand what that means for how much is already known about the safety of adding this hemoadsorption step to my dialysis treatment?
4One of the things this trial is measuring is quality of life alongside these toxin levels — given how dialysis already affects my daily routine, is there any existing evidence that lowering indoxyl sulfate or p-cresol sulfate actually makes patients feel better, or is that still an open question?
5Are there any standard or approved treatments we should try first to address protein-bound uremic toxin buildup before considering an experimental device like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, 3, 6, 9, 12 Months

Trial details

NCT IDNCT07656168

SponsorChina-Japan Friendship Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-04

Contact for this trial

Jian Lu, PhD

+8619834515101 lujiandr@163.com

View on ClinicalTrials.gov More ESRD (End-Stage Renal Disease) trials