NCT02378350

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)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 668 (actual)
• Sponsor: Vantive Health LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Hemodialysis treatment (no specific device is defined)
DRUG	Peritoneal Dialysis treatment (no specific drug is defined)

Timeline

• Start date: 2014-03-26
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2015-03-04
• Last updated: 2025-03-13

Locations

21 sites across 1 country: China