Multi-center Clinical Study on Hemoperfusion of KHA80

Not Applicable

Recruiting

• Conditions: Uremia; Uremic Osteodystrophy; Dialysis Related Complication

• Registration Number: NCT06233838
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-10
• Study Start: 2025-01-13
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-02-28
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 394

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 hemoperfutors;
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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China