A Randomized, Open-label, Multi-centre Trial Comparing Hemodialysis Plus Hemoperfusion Versus Hemodialysis Alone in Adult Patients With End-stage Renal Disease (HD/HPvsHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,362
- 试验地点
- 11
- 主要终点
- All-cause mortality
研究概览
简要总结
This multi-center, open-label, randomized controlled trial aims to investigate the efficacy of hemoperfusion (HP) combined with hemodialysis (HD) by evaluating all-cause mortality and cardiovascular mortality in maintenance hemodialysis patients.
详细描述
In this HD/HPvsHD trial, we plan to enroll 1364 maintenance hemodialysis patients. Eleven medical centers in Shanghai Metropolitan area have explicitly expressed interest to participate. Participants will be randomized to receive hemodialysis plus hemoperfusion or hemodialysis alone at a 1:1 ratio after 1-month run-in period. In both arms, patients will receive lBlood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment at least 10 hours per week. In the experiment group, in addition to the treatments in the control arm, hemoperfusion will be conducted at least once every two weeks using a HA130 resin hemoperfusion apparatus containing 130ml resin. Follow-up is scheduled at 3, 6, 12, 18, 24 and up to 48 months after randomization, and will consist the following: routine physical examinations, standard lab panels (blood routine, liver/kidney functions, tests of the coagulation system, etc.), chest X-ray, electrocardiogram, echocardiography, heart function rating (based on New York Heart Association grading). Dialysis adequacy defined by standard Kt/V will be calculated. Adverse events will be assessed according to the international conference on harmonization guidelines. The primary outcomes will include 24-month all-cause mortality. Secondary outcomes will include cardiovascular-related mortality, the occurrence of major cardiovascular events and the quality of life (Kidney Disease Quality of Life Short Form).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must meet all of the following criteria are eligible:
- •Age ≥ 18 years old
- •Regular blood purification treatment at least 3 months before enrolled in this study
- •3) Standard Kt/V ≥ 1.2
- •Subjects with one of more of the following conditions will be excluded:
- •White blood cell count < 4×10^9/L and / or platelet count < 100×10^9/L
- •Cerebral hemorrhage in the past 12 weeks
- •MACEs in the past 8 weeks
- •Severe heart failure (New York Heart Association [NYHA] class IV)
- •Active gastrointestinal bleeding, or coagulation dysfunction
- •Malignant tumor
- •Active infection
- •Pregnancy or lactation 9) Mental disabilities
排除标准
- 未提供
研究组 & 干预措施
regular hemodialysis
Blood purification (including low-flux hemodialysis, high-flux hemodialysis, or hemodiafiltration) treatment ≥10 hours per week
干预措施: hemodialysis (Device)
hemoperfusion combined with hemodialysis
Combination of hemodialysis and hemoperfusion treatment at least once every two week
干预措施: hemoperfusion combined with hemodialysis (Device)
hemoperfusion combined with hemodialysis
Combination of hemodialysis and hemoperfusion treatment at least once every two week
干预措施: hemodialysis (Device)
结局指标
主要结局
All-cause mortality
时间窗: From date of enrollment until the end of study, assessed up to 24 months
Compared the difference between standardized therapy and hemoperfusion combined with hemodialysis treatment
次要结局
- Cardiovascular-related mortality and major cardiovascular events (MACEs)(From date of enrollment until the end of study, assessed up to 24 months)
- Evaluation of quality of life(From date of enrollment until the end of study, assessed up to 24 months)
研究者
Gengru Jiang
Director of Renal Division, Department of Internal Medicine
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine