First Affiliated Hospital of Fujian Medical University
Phase
Not applicable
Started
2025-01-13
Last updated
2025-01-14
Condition(s) studied
UremiaUremic OsteodystrophyDialysis Related Complication
Investigational drug(s) / intervention(s)
KHA80 hemoperfusion treatment
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.
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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 sites (1)
Facility
City
Region
Status
The First Affiliated Hospital of Fujian Medical University
Fuzhou
Fujian
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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