跳至主要内容
临床试验/NCT04197674
NCT04197674Unknown不适用

China Q Cohort Study: an Extended Follow-up Study of PD vs. HD Randomized Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 903 人开始时间: 2020年1月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
903
试验地点
1
主要终点
Number of Participants died due to any cause

研究概览

简要总结

The burden of end-stage kidney disease (ESKD) is increasing worldwide. Although kidney transplantation is the most cost-effective renal replacement therapy, dialysis is still the main way to treat ESRD patients due to the limited kidney donor, with approximately 89% of such dialysis patients receive hemodialysis (HD) and the remainder receive peritoneal dialysis (PD). This distribution of dialysis modality, however, varies widely by health jurisdiction. For instance, more than 97% of dialysis patients are treated with HD in Japan, but more than 50% treated with PD in Mexico. Evidence comparing the two modalities suggests that mortality risks may be comparable, but all evidence come from observational study and there is no randomized controlled trial to compare patient survival between PD and HD due to patients enrollment issue.More importantly, for most health care systems, such as United States, United Kingdom, Australia, Indonesia and China, PD is less expensive than HD. It is possible, then, that a greater global utilization of PD might improve access to renal replacement therapy in less advanced economies.

The investigators have conducted a prospective, randomized, parallel, open-label, multi-center, non-inferiority trial to evaluate health-related quality of life (HRQoL) with PD versus conventional in-center HD in incident ESKD patients. A total of 1082 ESKD patients were randomly assigned to PD or conventional in-center HD, and 235 patients enrolled in stage 1 with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks and 668 patients enrolled in stage 2 were included in analysis. However, this trial was designed to evaluate quality of life between PD and HD and all patients were follow-up 48 weeks. Therefore, in this observational cohort study, the investigators will perform extended follow-up for participants including in analysis . Our primary objective is to evaluate the association of dialysis modality (PD and HD) with all-cause mortality in ESKD patients. The investigators also explore the impact of PD and HD on major cardiovascular event composite (MACE), a composite outcome of MACE and all-cause death, hospitalized myocardial infarction, hospitalized stroke and hospitalized heart failure, healthy utility, dialysis cost, activity of daily living, and changes of RRF, hemoglobin, and other biochemical parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (age ≥ 18 years old) peritoneal dialysis or in-center hemodialysis patient who have been recruited in previous China Q study and who enrolled in SURinD study with complete measures of the "Burden of Kidney Disease" at both baseline and 48 weeks.
  • Will and able to provide the informed consent form (ICF).

排除标准

  • Patients have stopped dialysis due to kidney function recovery or kidney transplantation.
  • Patients refuse to provide consent.

结局指标

主要结局

Number of Participants died due to any cause

时间窗: From the first day receiving assigned treatment to the end of 3rd year follow-up

Patients died due to any cause

次要结局

  • Number of Participants with major cardiovascular event composite (MACE)(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Changes of activity of daily living(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Number of Participants with composite outcome of MACE and all-cause death(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Rate of difference in dialysis cost between PD and HD(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Changes of residual renal function(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Changes of serum albumin(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Number of Participants with hospitalized myocardial infarction, stroke and heart failure(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Changes of serum phosphors(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Healthy utility(From the first day receiving assigned treatment to the end of 3rd year follow-up)
  • Changes of hemoglobin(From the first day receiving assigned treatment to the end of 3rd year follow-up)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xue Qing Yu

Professor

Sun Yat-sen University

研究点 (1)

Loading locations...

相似试验