Multi-center Clinical Study on Hemoperfusion of KHA80

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233838
• Other study ID #: 8339-001
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dialysis Related Complication
• Uremia
• Uremic Osteodystrophy

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

External Links

•   Combination of maintenance hemodialysis with hemoperfusion: a safe and effective model of artificial kidney
•   Plasma interlcukin-6 predicts cardiovascular mortality in hemodialysis patients
•   Predicting 3-year mortality based on thetumornecrosis factor alpha concentration in low-flux hemodialysis patients
•   The microinflammatory state in uremia: causes and potential consequences.