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Multi-center Clinical Study on Hemoperfusion of KHA80

RecruitingNAAges 18 Years - anyAllFirst Affiliated Hospital of Fujian Medical Unive…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • KHA80 hemoperfusion treatment
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Where

1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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