Search / Trial NCT06233838

Multi-center Clinical Study on Hemoperfusion of KHA80

Launched by FIRST AFFILIATED HOSPITAL OF FUJIAN MEDICAL UNIVERSITY · Jan 22, 2024

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Trial Information

Current as of October 08, 2024

Not yet recruiting

Keywords

Kha80 Maintenance Hemodialysis Il 6 β2 Mg Pth

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 tr...

Gender

ALL

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 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.

About First Affiliated Hospital Of Fujian Medical University

The First Affiliated Hospital of Fujian Medical University is a leading medical institution dedicated to advancing healthcare through innovative clinical research and education. As a premier sponsor of clinical trials, the hospital is committed to improving patient outcomes and contributing to medical knowledge across various specialties. With a robust infrastructure and a multidisciplinary team of experienced researchers and healthcare professionals, the hospital ensures the ethical conduct and scientific rigor of its trials, fostering collaboration with global research communities. Its mission is to enhance the quality of care through evidence-based practices and to support the development of novel therapies that address unmet medical needs.

Locations

Fuzhou, Fujian, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0