Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

End Stage Renal Disease Clinical Trial

Official title: A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

• NCT number: NCT02378350
• Study type: Interventional
• Source: Baxter Healthcare Corporation
• Status: Completed
• Phase: Phase 4
• Start date: March 26, 2014
• Completion date: September 18, 2017