Effect of pHA130 Hemoadsorption with Hemodialysis in Kidney Failure
Official title: A Prospective, Multicenter, Randomized Controlled Trial of HAHD With pHA130 Cartridge vs. Conventional High-Flux HD for Clearance of Protein-Bound Uremic Toxins and Quality of Life Improvement in Kidney Failure.
Run by China-Japan Friendship Hospital · NCT07656168 · Data updated 2026-11-12
Aims to see if adding the pHA130 hemoadsorption cartridge to dialysis helps reduce protein-bound toxins in people with end-stage kidney failure on maintenance dialysis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | China-Japan Friendship Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Status | Recruiting |
| Started | June 1, 2026 |
| Main results expected | April 2028 |
| Study ends | August 2028 |
| Registry record updated | June 25, 2026 |
| Trial ID | NCT07656168 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with ESRD on maintenance hemodialysis for at least 3 months, receiving standard thrice-weekly dialysis with adequate dialysis adequacy (Kt/V ≥ 1.2).
✕Probably not a fit
Patients who cannot tolerate additional extracorporeal therapy or have contraindications to the hemoadsorption device may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter, open-label trial tests whether combining pHA130 hemoadsorption with standard hemodialysis lowers levels of protein-bound uremic toxins in patients receiving maintenance dialysis. Adults on three-times-weekly dialysis are randomized to receive one HAHD session per week plus two HD sessions, or three HD sessions alone, over a defined period. The study tracks changes in toxins such as indoxyl sulfate and p-cresyl sulfate, safety, and subjective quality of life. The intervention uses a modified resin cartridge designed to adsorb PBUTs during the dialysis process. The trial is designed to provide evidence on whether this approach can improve clinical outcomes and toxin clearance in ESRD.
Why it matters
Potential benefit: If successful, patients may experience lower toxin burden and potentially improvements in cardiovascular risk factors and quality of life.
How similar studies have gone: Prior in vitro work suggested high PBUT clearance with pHA130; clinical translation of benefits remains to be demonstrated in randomized trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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China-Japan Friendship Hospital
Beijing, China Recruiting
Study contacts
- Principal investigator: Wenge Li, MD — China-Japan Friendship Hospital
- Study coordinator: Jian Lu, PhD
- Email: lujiandr@163.com
- Phone: +8619834515101
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.