Uremia Clinical Trial
Official title:
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
Verified date | January 2024 |
Source | First Affiliated Hospital of Fujian Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 394 |
Est. completion date | February 28, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 ß 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 perfusers; 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Fujian Medical University | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Fujian Medical University |
China,
Chen SJ, Jiang GR, Shan JP, Lu W, Huang HD, Ji G, Wu P, Wu GF, Wang W, Zhu C, Bian F. Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney. Int J Artif Organs. 2011 Apr;34(4):339-47. doi: 10.5301/IJAO.2011.7748. — View Citation
Kaysen GA. The microinflammatory state in uremia: causes and potential consequences. J Am Soc Nephrol. 2001 Jul;12(7):1549-1557. doi: 10.1681/ASN.V1271549. — View Citation
Rao M, Guo D, Perianayagam MC, Tighiouart H, Jaber BL, Pereira BJ, Balakrishnan VS. Plasma interleukin-6 predicts cardiovascular mortality in hemodialysis patients. Am J Kidney Dis. 2005 Feb;45(2):324-33. doi: 10.1053/j.ajkd.2004.09.018. — View Citation
Thang LV, Loc ND, Dung NH, Kien NT, Quyen DBQ, Tuan NM, Ha DM, Kien TQ, Dung NTT, Van DT, Van Duc N, Ha NTT, Toan PQ, Usui T, Nangaku M. Predicting 3-year mortality based on the tumor necrosis factor alpha concentration in low-flux hemodialysis patients. Ther Apher Dial. 2020 Oct;24(5):554-560. doi: 10.1111/1744-9987.13463. Epub 2020 Jan 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the rate of change of IL-6, ß2-MG and PTH i | the rate of change of IL-6, ß2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis. | in the 52nd week |
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