NCT07656168Recruiting
Efficacy of pHA130 Hemoadsorption on Protein-Bound Uremic Toxins and Quality of Life in Kidney Failure
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.
Source: ClinicalTrials.gov · Last updated 25 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 9 May 2026
- Start date
- 1 Jun 2026
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- China-Japan Friendship Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT07656168
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jun 2026 to the primary completion date, 30 Apr 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Known allergy to the dialyzer or hemoperfusion device.
- Coagulation disorders, severe bleeding tendency, or active bleeding.
- Active malignancy.
- Active infection, or severe, critical illness of cardiac, pulmonary, hepatic, or nervous systems.
- History of unstable angina, myocardial infarction, malignant arrhythmia, cardiac or peripheral vascular surgery, or cerebrovascular accident within the past 8 weeks.
Lab values
- Platelet count \< 60×10⁹/L.
- Serum albumin \< 30 g/L.
Other
- 24-hour urine output \> 200 ml.
- Inability to achieve a blood flow rate ≥ 200 ml/min.
- Pre-dialysis systolic blood pressure \< 90 mmHg or diastolic blood pressure \< 60 mmHg.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| China-Japan Friendship Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.