A Multi-center, Open-label, Randomized Trial of Hemodialysis Plus Hemoperfusion on Blood β2-microglobulin (β2-MG), Parathyroid Hormone (PTH) and C Reactive Protein (CRP) Clearance in Maintenance Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Changes in blood C Reactive Protein (CRP) values
研究概览
简要总结
This multi-center, open-label, randomized, parallel controlled trial aims to investigate the efficacy of hemoperfusion (HP) in combination with hemodialysis (HD) by assessing blood β2-microglobulin (β2-MG), parathyroid hormone (PTH) and C reactive protein (CRP) clearance in maintenance hemodialysis patients.
详细描述
In this HD/HP vs HD trial, the investigators plan to enroll 410 maintenance hemodialysis patients. Twelve medical centers in the Shanghai metropolitan area have expressed interest in participating. Participants will be randomized into 2 groups after a 1-month washout period. The control group (205 patients) will be treated with hemodialysis or hemofiltration with a frequency of 3 times/week; the experimental group (205 patients) will be treated with Jafron KHA80 hemoperfusion apparatus in addition to hemodialysis or hemofiltration with a frequency of 1 time/week. Follow-up data before the last dialysis at 4, 12, 24, 36 and 52 weeks of treatment were collected from both groups, including the following: routine physical examination, laboratory tests (blood routine, blood biochemistry, β2-MG, PTH, CRP, liver/kidney function, coagulation system tests, etc.), chest X-ray, electrocardiogram and cardiac ultrasound. Dialysis adequacy as defined by standard Kt/V will be calculated. Comorbidities, combined medications and adverse events will also be captured. The primary outcomes will include change in blood β2-MG, PTH and CRP values. Secondary outcomes will include change values for serum protein-bound toxins (e.g., p-Cresol sulfate, indophenol sulphate), improvement in patient quality of life (Kidney Disease Quality of Life Short Form), sleep disturbance (Pittsburgh Sleep Quality Index) and pruritus (Duo's pruritus score).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years, regardless of gender
- •Stable maintenance hemodialysis for ≥ 3 months with relatively fixed dialysis pattern
- •Hemodialysis treatment 3 times per week, total treatment duration ≥ 10 hours per week, vascular access unlimited
- •Blood β2-MG > 30 mg/L and/or 300 pg/ml < immunoreactive parathyroid hormone (iPTH) < 800 pg/ml and/or CRP ≥ 16.2 pg/ml
- •Kt/V ≥ 1.2 eight weeks prior to enrollment
- •Signed informed consent form
排除标准
- •Known allergic reaction, contraindication or intolerance to the material of the dialyzer or perfusion apparatus
- •Test indicators meeting one or more of the following: white blood cell <4 x 10^9/L, platelet count <60 x 10^9/L, serum albumin <30 g/L
- •Blood flow <200 ml/min
- •Regular hemoperfusion treatment for more than 3 months and at least once every 2 weeks
- •Active bleeding or chronic gastrointestinal bleeding, or other severe bleeding tendencies or coagulation disorders
- •History of unstable angina pectoris, myocardial infarction, severe arrhythmia, pericarditis, myocarditis, cardiac surgery or peripheral vascular surgery in the last 8 weeks
- •Cerebral hemorrhage in the last 12 weeks
- •Severe heart failure (New York Heart Association class IV)
- •Acute infection, acute or critical illnesses such as severe cardiac, pulmonary, hepatic or neurological disease and malignancy
- •Pregnancy or breastfeeding
- •Participation in a clinical trial or ongoing clinical trial within 3 months
- •Expected survival of less than 1 year
- •Not considered suitable for participation in this trial by the investigator
结局指标
主要结局
Changes in blood C Reactive Protein (CRP) values
时间窗: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood CRP in maintenance hemodialysis patients
Changes in blood β2-microglobulin (β2-MG) values
时间窗: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood β2-MG in maintenance hemodialysis patients
Changes in blood Parathyroid Hormone (PTH) values
时间窗: From date of enrollment until the end of study, assessed up to 52 weeks
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment on the clearance of blood PTH in maintenance hemodialysis patients
次要结局
- Change in serum protein-bound toxin (e.g., p-Cresol sulfate, indophenol sulphate) values(From date of enrollment until the end of study, assessed up to 52 weeks)
- Improvement in patients' quality of life(From date of enrollment until the end of study, assessed up to 52 weeks)
- Improvement in patients' pruritus(From date of enrollment until the end of study, assessed up to 52 weeks)
- Improvement in patients' sleep disturbance(From date of enrollment until the end of study, assessed up to 52 weeks)