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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
KHA80 hemoperfusion treatment
DeviceOn the basis of hemodialysis or hemodiafiltration treatment, Jianfan KHA80 hemoperfusion treatment was given, and the frequency of hemoperfusion treatment was ≥2 times/month.
Treatment groups
394 Participants
are divided into 2 treatment groupsGroup A: KHA80 hemoperfusion treatmentExperimental treatment 1 intervention
Group B: Routine hemodialysisNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
the rate of change of IL-6, β2-MG and PTH
the rate of change of IL-6, β2-MG and PTH in the 52nd week of maintenance hemodialysis patients compared with routine hemodialysis.
Time frame
in the 52nd weekSponsors and contacts
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Source ClinicalTrials.gov