Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure
Recruiting · NCT07656168 · Interventional (participants receive a specific treatment) · Lead sponsor: China-Japan Friendship Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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 is running
1 location listed.
- China-Japan Friendship Hospital - Beijing, China