NCT02378350

Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

Completed Phase 4 Last updated 13 March 2025

What this trial tests

Phase 4 trial testing Hemodialysis treatment (no specific device is defined) in End Stage Renal Disease in 668 participants. Completed in 18 September 2017.

Timeline

26 March 2014

Primary endpoint
18 September 2017

18 September 2017

Quick facts

Lead sponsor	Vantive Health LLC
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	668
Start date	26 March 2014
Primary completion	18 September 2017
Estimated completion	18 September 2017
Sites	21 locations across China

Drugs / interventions tested

• Hemodialysis treatment (no specific device is defined)
• Peritoneal Dialysis treatment (no specific drug is defined) — full drug profile →

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →

Sponsor

Vantive Health LLC — full company profile →

Who can join

18 and older, any sex, with End Stage Renal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Comparison of Patient-Reported Outcome Measures of Quality of Life By Dialysis Modality in the Treatment of Kidney Failure: A Systematic Review.
   Budhram B, Sinclair A, Komenda P, Severn M, et al · · 2020 · cited 25× · PMID 33149924 · DOI 10.1177/2054358120957431
2. Peritoneal dialysis versus haemodialysis for people commencing dialysis.
   Ethier I, Hayat A, Pei J, Hawley CM, et al · · 2024 · cited 11× · PMID 38899545 · DOI 10.1002/14651858.cd013800.pub2
3. Outcomes and practice patterns with hemodiafiltration in Shanghai: a longitudinal cohort study.
   Zhang W, Mei C, Chen N, Ding X, et al · · 2019 · cited 3× · PMID 30709342 · DOI 10.1186/s12882-019-1219-z