Multi-center Clinical Study on Hemoperfusion of KHA80

NCT06233838 | Recruiting

• 1 other identifier: 8339-001
• Study Type: interventional
• Target: 394
• Locations: 1 country
• Sites: 1

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.

Conditions

Uremia; Uremic Osteodystrophy; Dialysis Related Complication

Keywords

KHA80; Maintenance hemodialysis; IL-6; β2-MG; PTH

Outcome Measures

Primary Outcomes (1)

• the rate of change of IL-6, β2-MG and PTH

  the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis.

  in the 52nd week

Study Arms (2)

KHA80 hemoperfusion treatment

EXPERIMENTAL

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.

Device: KHA80 hemoperfusion treatment

Routine hemodialysis

NO INTERVENTION

Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week.

Interventions

KHA80 hemoperfusion treatment DEVICE

On the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.

KHA80 hemoperfusion treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old, regardless of sex;
• According to the 2012 KDIGO guidelines, it was diagnosed as CKD5 (EGFR ≦ 15ml/(min ˙ 1.73m2));
• receive regular hemodialysis (including hemodialysis filtration) for 4 hours twice a week for ≧3 months;
• blood β 2-mg ≥ 30 mg/L and/or PTH ≥ 600 pg/mL and/or IL-6 ≥ 16.2 pg/mL;
• Sign the informed consent form.

You may not qualify if:

• Those who are known to have allergic reactions, contraindications or intolerance to the materials of dialyzers and hemoperfutors;
• Patients with severe bleeding tendency and active bleeding, or with definite coagulation dysfunction, with a platelet count of \< 60× 109/L;
• Hemodialysis blood flow \< 200 ml/min.
• Kt/V\<1.2；
• Serum albumin \< 30g/L;
• Parathyroid resection within one year;
• people with low blood pressure and severe cardiopulmonary insufficiency;
• lactating or pregnant women or those who plan to be pregnant within one year;
• infection, history of malignant tumor, active stage of rheumatic immune disease;
• Patients whose life expectancy is less than one year;
• Other clinical researchers are currently or recently (within 30 days);
• According to the researcher's judgment, the patient has other unsuitable conditions.

Sponsors & Collaborators

• First Affiliated Hospital of Fujian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

RECRUITING

Related 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.

  PMID: 21534244 BACKGROUND

• 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.

  PMID: 11423586 BACKGROUND

• 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.

  PMID: 15685511 BACKGROUND

• 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.

  PMID: 31856402 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Uremia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 31, 2024
• Study Start: January 13, 2025
• Primary Completion: February 28, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)