Abstract: TH-PO1149
Primary Results of the Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (China Q) Study: A Prospective, Randomized, Open-Label, Multicenter, Noninferiority Trial
Session Information
- Late-Breaking Clinical Trials Posters
October 25, 2018 | Location: Exhibit Hall, San Diego Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Dialysis
- No subcategory defined
Authors
- Yu, Xueqing, Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Fan, Li, Department of Nephrology, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
- Marshall, Mark R., Middlemore Hospital, Auckland, New Zealand
Group or Team Name
- the China Q study investigators
Background
There may be differences in health-related quality of life between hemodialysis (HD) and peritoneal dialysis (PD) for incident end-stage renal disease (ESRD) patients, but this hypothesis has not been adequately tested.
Methods
Open-label clinical trial from 21 centers in China, in adults diagnosed with new ESRD requiring maintenance dialysis, randomized 1:1 to receive in-center HD (≥3 x 4 hour sessions/week) or PD (3-5 exchanges/day). Primary end-point was burden of kidney disease score from the KDQoL-SF at 48 weeks; main secondary endpoint was all-cause mortality at 48 weeks. This dataset was supplemented by 235 patients (142 PD, 93 HD) from the previously terminated SURinD trial, who had complete measures of burden of kidney disease at both baseline and 48 weeks. The primary endpoint was assessed in the per protocol (PP) population, with a sensitivity analysis in the intention-to-treat (ITT) population. The treatment effect between arms was represented by the geometric mean (GM) ratio, and non-inferiority defined by the lower bound of 1-side 95% CI of GM ratio > 0.9 after 48 weeks follow-up. The main secondary end-point was assessed only in the China Q ITT population (NCT02378350, NCT01413074).
Results
336 incident patients allocated to HD (237 per protocol), 332 to PD (253 per protocol) between Apr 2014 to Jun 2016. Patients were representative of those in China, with a pooled mean (SD) age of 49.5 (14.7) years, and 370 females (41.0%). For the primary endpoint, the GM ratio (95% CI) of PD vs. HD was 1.06 (0.91, 1.24), exceeding the limit for non-inferiority (p=0.43). The result of the sensitivity analysis was similar. There were 13 deaths in the PD group, and 19 deaths in the HD group, with no difference between groups (p=0.94).
Conclusion
In this study, burden of kidney disease was not inferior with PD vs. in-center HD, suggesting comparable perceptions of frustration and interference of kidney disease in one’s life. Mortality risk was not different, although the study was not powered for this end-point. Analysis of other KDQoL-SF endpoints, clinical endpoints, and hospitalization are ongoing.
Funding
- Commercial Support –