Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
- Conditions
- End Stage Renal Disease
- Interventions
- Device: Hemodialysis treatment (no specific device is defined)Drug: Peritoneal Dialysis treatment (no specific drug is defined)
- Registration Number
- NCT02378350
- Lead Sponsor
- Vantive Health LLC
- Brief Summary
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-SFâ„¢ (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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 668
- 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
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Subjects who are HIV positive
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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
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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
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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
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Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
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Subjects who are currently using any investigational drug
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Subjects who are currently enrolled in other clinical studies
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Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
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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
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Subjects who have a malignancy requiring chemotherapy or radiation therapy
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Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
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Subjects who have a life expectancy of < 48 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ESRD patients receiving HD treatment Hemodialysis treatment (no specific device is defined) no investigational drug involved. Only observe therapy treatment ESRD patients receiving PD treatment Peritoneal Dialysis treatment (no specific drug is defined) no investigational drug involved. Only observe therapy treatment
- Primary Outcome Measures
Name Time Method 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire 1 year
- Secondary Outcome Measures
Name Time Method Mortality rates 1 year 24-hour urine volume 1 year Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance 1 year Cause of death 1 year Dialysis adequacy 1 year Change in hemoglobin 1 year Change in serum albumin 1 year Change in S-phosphate levels 1 year Switch (PD to HD or HD to PD) 1 year Transplantation rate 1 year
Trial Locations
- Locations (21)
Guangzhou Panyu Central Hospital
🇨🇳Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
The 2nd Shenzhen Municipal People's Hospital
🇨🇳Shenzhen, Guangdong, China
Guizhou Province People's Hospital
🇨🇳Guiyang, Guizhou, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital , Sun Yet-Sen University
🇨🇳Guangzhou, Guangdong, China
Lanzhou University Second Hospital
🇨🇳Lanzhou, Gansu, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Traditional Chinese Medicine Hospital of Wuhan
🇨🇳Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Jiangxi province people's hospital
🇨🇳Nanchang, Jiangxi, China
Nanchang First Affiliated Hospital
🇨🇳Nanchang, Jiangxi, China
First Hospital of Affiliated of Dalian Medical University
🇨🇳Dalian, Liaoning, China
General Hospital of Ningxia Medical University
🇨🇳Yingchuan, Ningxia, China
Renji Hospital , Shanghai Jiaotong University , School of Medicine
🇨🇳Shanghai, Shanghai, China
Shanghai 455 Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Tenth People's Hospital
🇨🇳Shanghai, Shanghai, China
Shanghai Xinhua Hospital
🇨🇳Shanghai, Shanghai, China
Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
The First Affiliated Hospital of Tianjin University of TCM
🇨🇳Tianjin, Tianjin, China