Clinical trial NCT06233838: Multi-center Clinical Study on Hemoperfusion of KHA80
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Uremia
Uremic Osteodystrophy
Dialysis Related Complication
Keywords: KHA80
Maintenance hemodialysis
IL-6
β2-MG
PTH
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 394
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected.

Eligibility 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.

Primary outcomes:
measure: the rate of change of IL-6, β2-MG and PTH
timeFrame: in the 52nd week
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
citation: 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.
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.
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.
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.