Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
Status:
Completed
Trial end date:
2017-09-18
Target enrollment:
Participant gender:
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-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