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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06233838
Other study ID # 8339-001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2024
Est. completion date February 28, 2025

Study information

Verified date January 2024
Source First Affiliated Hospital of Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Intervention

Device:
KHA80 hemoperfusion treatment
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

Country Name City State
China The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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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