Multi-center Clinical Study on Hemoperfusion of KHA80
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFirst Affiliated Hospital of Fujian Medical University
About this trial
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 criteria
Qualifiers
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;
Disqualifiers
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；
Trial design
Treatments tested in this trial
- KHA80 hemoperfusion treatment
Treatment groups
394 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov