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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- the rate of change of IL-6, β2-MG and PTH
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
KHA80 hemoperfusion treatment
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.
干预措施: KHA80 hemoperfusion treatment (Device)
Routine hemodialysis
Randomly assign the control group (197 cases) to receive hemodialysis or hemodialysis filtration treatment, and the frequency of treatment is ≥2 times/week.
结局指标
主要结局
the rate of change of IL-6, β2-MG and PTH
时间窗: 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.
次要结局
未报告次要终点
研究者
wanjianxin
Clinical Professor
First Affiliated Hospital of Fujian Medical University