RecruitingNot Applicable

Multi-center Clinical Study on Hemoperfusion of KHA80

China394 participantsStarted 2025-01-13

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;

What they're measuring

the rate of change of IL-6, β2-MG and PTH

Timeframe: in the 52nd week

Trial details

NCT IDNCT06233838

SponsorFirst Affiliated Hospital of Fujian Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-02-28

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