Multi-center Clinical Study on Hemoperfusion of KHA80
Recruiting now · Not applicable
Conditions studied: Uremia, Uremic Osteodystrophy, Dialysis Related Complication
In brief
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.
Key facts
- Study ID
- NCT06233838
- Run by
- First Affiliated Hospital of Fujian Medical University
- People needed
- 394
- Starts
- 2025-01-13
- Expected to finish
- 2027-05-31
- Last updated by the study team
- 2025-01-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (enrolling)
Full record on ClinicalTrials.gov
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