Multi-center Clinical Study on Hemoperfusion of KHA80
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
First Affiliated Hospital of Fujian Medical University
394 participants
Jan 13, 2025
INTERVENTIONAL
Conditions
Summary
To evaluate the decreasing rate of blood IL-6, β2-MG and PTH in maintenance hemodialysis patients in the 52nd week compared with routine hemodialysis.
Eligibility
Inclusion Criteria5
- Age ≥18 years old, regardless of sex;
- According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
- receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
- blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
- Sign the informed consent form.
Exclusion Criteria12
- Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
- Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
- Hemodialysis blood flow \< 200 ml/min.
- Kt/V\<1.2；
- Serum albumin \< 30g/L;
- Parathyroid resection within one year;
- people with low blood pressure and severe cardiopulmonary insufficiency;
- lactating or pregnant women or those who plan to be pregnant within one year;
- infection, history of malignant tumor, active stage of rheumatic immune disease;
- Patients whose life expectancy is less than one year;
- Other clinical researchers are currently or recently (within 30 days);
- According to the researcher's judgment, the patient has other unsuitable conditions.
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Interventions
On the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.
Locations(1)
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NCT06233838