Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-03 @ 10:21 PM
Study NCT ID:
NCT02378350
Status:
COMPLETED
Last Update Posted:
2025-03-13
First Post:
2015-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
Sponsor:
Vantive Health LLC
Organization:
Study Overview
Official Title:
A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: