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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
668
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital , Sun Yet-Sen University
Guangzhou, Guangdong, China
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 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
...and 11 more locations
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
Time frame: 1 year
Mortality rates
Time frame: 1 year
Switch (PD to HD or HD to PD)
Time frame: 1 year
Transplantation rate
Time frame: 1 year
Cause of death
Time frame: 1 year
Dialysis adequacy
Time frame: 1 year
24-hour urine volume
Time frame: 1 year
Change in hemoglobin
Time frame: 1 year
Change in serum albumin
Time frame: 1 year
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Time frame: 1 year
Change in S-phosphate levels
Time frame: 1 year
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