Prospective, Multicenter, Randomized, Open Label Study on the Efficacy and Safety of Comparison of KHA80 Blood Perfusion Combined With Hemodialysis and Conventional Hemodialysis in Clearing IL-6, β2-MG and PTH in Maintenance Hemodialysis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 394
- Locations
- 1
- Primary Endpoint
- the rate of change of IL-6, β2-MG and PTH
Study Overview
Brief 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.
Detailed Description
394 patients with maintenance hemodialysis were included in the study, and the blood purification time was ≥8 hours per week (including routine hemodialysis, high-throughput hemodialysis, hemodialysis filtration, hemoperfusion, etc.). Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week; The experimental group (197 cases) were randomly assigned to receive Jianfan KHA80 hemoperfusion treatment on the basis of hemodialysis or hemodiafiltration treatment, and the frequency of hemoperfusion treatment was ≥2 times/month. The follow-up data of 0, 4, 12, 24, 36 and 52 weeks of treatment in the two groups were collected, and the information of combined medication and adverse events was also collected.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
the rate of change of IL-6, β2-MG and PTH
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
wanjianxin
Clinical Professor
First Affiliated Hospital of Fujian Medical University