Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire domain of burden of kidney disease.
Secondary Objectives: The secondary objectives are to observe and summarize the following parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items, which will be compared between the 2 treatment groups:
- Mortality rates
- Switch (PD to HD or HD to PD)
- Transplantation rate
- Cause of death
- Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the volume of distribution of urea [Kt/V urea] to determine the proportion of subjects meeting standards of care for dialysis adequacy).
- 24-hour urine volume
- Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values within the target range
- Change in serum albumin
- Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
研究概览
地位
条件
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Fujian
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Fuzhou、Fujian、中国
- The First Affiliated Hospital of Fujian Medical University
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Gansu
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Lanzhou、Gansu、中国
- Lanzhou University Second Hospital
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Guangdong
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Guangzhou、Guangdong、中国
- The Third Hospital of Sun Yat-Sen University
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Guangzhou、Guangdong、中国、510080
- The First Affiliated Hospital , Sun Yet-Sen University
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Guangzhou City、Guangdong、中国
- Guangzhou Panyu Central Hospital
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Shenzhen、Guangdong、中国
- The 2nd Shenzhen Municipal People's Hospital
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Guizhou
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Gui Yang City、Guizhou、中国
- GuiZhou Province People's Hospital
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Heilongjiang
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Harbin City、Heilongjiang、中国
- The Second Affiliated Hospital of Harbin Medical University
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Hubei
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Wuhan City、Hubei、中国
- Traditional Chinese Medicine Hospital of Wuhan
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Hunan
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Changsha、Hunan、中国
- The Third Xiangya Hospital of Central South University
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Jiangsu
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Suzhou、Jiangsu、中国
- The Second Affiliated Hospital of Soochow University
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Jiangxi
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Nanchang、Jiangxi、中国
- Jiangxi province people's hospital
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Nangchang、Jiangxi、中国
- Nanchang First Affiliated Hospital
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Liaoning
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Dalian、Liaoning、中国
- First Hospital of Affiliated of Dalian Medical University
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Ningxia
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Yingchuan、Ningxia、中国
- General Hospital of Ningxia Medical University
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Shanghai
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Shanghai、Shanghai、中国
- Shanghai Xinhua hospital
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Shanghai、Shanghai、中国
- Shanghai Tenth People's Hospital
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Shanghai、Shanghai、中国、200127
- Renji Hospital , Shanghai Jiaotong University , School of Medicine
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Shanghai、Shanghai、中国
- Shanghai 455 Hospital
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Sichuan
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Chengdu、Sichuan、中国
- Sichuan Provincial People's Hospital
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Tianjin
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Tianjin、Tianjin、中国
- The First Affiliated Hospital of Tianjin University of TCM
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
- Male or female subjects aged 18 years or older at the time of randomization
- Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF
- Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF
- Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
- Subjects who are able to adhere to the study visit schedule and other protocol requirements
- Subjects who are able to come to HD clinics as required by the protocol
- Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks
- Subjects who have normal liver function, as judged by the Investigator
- Female subjects of childbearing potential must have negative serum or urine pregnancy test at Screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the Investigator, while in the study
Exclusion Criteria:
- Subjects who are HIV positive
- Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload
- Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study
- Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening
- Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
- Subjects who are currently using any investigational drug
- Subjects who are currently enrolled in other clinical studies
- Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to:
- Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated
- Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated
- Subjects who have a malignancy requiring chemotherapy or radiation therapy
- Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
- Subjects who have a life expectancy of < 48 weeks
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
有源比较器:ESRD patients receiving HD treatment
no investigational drug involved.
Only observe therapy treatment
|
|
实验性的:ESRD patients receiving PD treatment
no investigational drug involved.
Only observe therapy treatment
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
大体时间:1 year
|
1 year
|
次要结果测量
结果测量 |
大体时间 |
---|---|
Mortality rates
大体时间:1 year
|
1 year
|
Switch (PD to HD or HD to PD)
大体时间:1 year
|
1 year
|
Transplantation rate
大体时间:1 year
|
1 year
|
Cause of death
大体时间:1 year
|
1 year
|
Dialysis adequacy
大体时间:1 year
|
1 year
|
24-hour urine volume
大体时间:1 year
|
1 year
|
Change in hemoglobin
大体时间:1 year
|
1 year
|
Change in serum albumin
大体时间:1 year
|
1 year
|
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
大体时间:1 year
|
1 year
|
Change in S-phosphate levels
大体时间:1 year
|
1 year
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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