Evaluation of KHA80 hemoperfusion in hemodialysis patients
Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients
This study is testing if adding KHA80 hemoperfusion to regular hemodialysis can lower certain harmful substances in the blood for patients who are on hemodialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 394 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06233838 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of KHA80 hemoperfusion treatment in reducing blood levels of IL-6, β2-MG, and PTH in patients undergoing maintenance hemodialysis. A total of 394 patients will be randomly assigned to either a control group receiving standard hemodialysis or an experimental group receiving KHA80 hemoperfusion in addition to their regular treatment. The study will monitor patients over 52 weeks, collecting data on treatment outcomes and any adverse events. The goal is to determine if KHA80 can provide additional benefits compared to routine hemodialysis alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with chronic kidney disease stage 5 requiring regular hemodialysis and elevated levels of β2-MG, PTH, or IL-6.
Not a fit: Patients with severe bleeding disorders, active bleeding, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of uremia and related complications in hemodialysis patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients undergoing hemodialysis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥18 years old, regardless of sex; 2. According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2)); 3. receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months; 4. blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL; 5. Sign the informed consent form. Exclusion Criteria: 1. Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors; 2. Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L; 3. Hemodialysis blood flow \< 200 ml/min. 4. Kt/V\<1.2； 5. Serum albumin \< 30g/L; 6. Parathyroid resection within one year; 7. people with low blood pressure and severe cardiopulmonary insufficiency; 8. lactating or pregnant women or those who plan to be pregnant within one year; 9. infection, history of malignant tumor, active stage of rheumatic immune disease; 10. Patients whose life expectancy is less than one year; 11. Other clinical researchers are currently or recently (within 30 days); 12. According to the researcher's judgment, the patient has other unsuitable conditions.
Where this trial is running
Fuzhou, Fujian
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.