Multi-center Clinical Study on Hemoperfusion of KHA80

Last updated: January 10, 2025
Sponsor: First Affiliated Hospital of Fujian Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nephropathy

Kidney Failure (Pediatric)

Kidney Failure

Treatment

KHA80 hemoperfusion treatment

Clinical Study ID

NCT06233838
8339-001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 aweek 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

Exclusion Criteria:

  1. Those who are known to have allergic reactions, contraindications or intolerance tothe materials of dialyzers and hemoperfutors;

  2. Patients with severe bleeding tendency and active bleeding, or with definitecoagulation 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

Total Participants: 394
Treatment Group(s): 1
Primary Treatment: KHA80 hemoperfusion treatment
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
May 31, 2027

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350000
    China

    Active - Recruiting

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