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)
1 other identifier
interventional
668
1 country
21
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2014
Longer than P75 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 26, 2014
CompletedFirst Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2017
CompletedMarch 13, 2025
March 1, 2025
3.5 years
February 10, 2015
March 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
1 year
Secondary Outcomes (10)
Mortality rates
1 year
Switch (PD to HD or HD to PD)
1 year
Transplantation rate
1 year
Cause of death
1 year
Dialysis adequacy
1 year
- +5 more secondary outcomes
Study Arms (2)
ESRD patients receiving HD treatment
ACTIVE COMPARATORno investigational drug involved. Only observe therapy treatment
ESRD patients receiving PD treatment
EXPERIMENTALno investigational drug involved. Only observe therapy treatment
Interventions
Eligibility Criteria
You may qualify if:
- Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
- Male or female subjects aged 18 years or older at the time of randomization
- Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF
- Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF
- Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
- Subjects who are able to adhere to the study visit schedule and other protocol requirements
- Subjects who are able to come to HD clinics as required by the protocol
- Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks
- Subjects who have normal liver function, as judged by the Investigator
- Female subjects of childbearing potential must have negative serum or urine pregnancy test at Screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the Investigator, while in the study
You may not qualify if:
- Subjects who are HIV positive
- Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload
- Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study
- Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening
- Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
- Subjects who are currently using any investigational drug
- Subjects who are currently enrolled in other clinical studies
- Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
- Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to:
- Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated
- Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated
- Subjects who have a malignancy requiring chemotherapy or radiation therapy
- Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
- Subjects who have a life expectancy of \< 48 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantive Health LLClead
- Baxter Healthcare Corporationcollaborator
Study Sites (21)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital , Sun Yet-Sen University
Guangzhou, Guangdong, 510080, China
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
The 2nd Shenzhen Municipal People's Hospital
Shenzhen, Guangdong, China
Guizhou Province People's Hospital
Guiyang, Guizhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Traditional Chinese Medicine Hospital of Wuhan
Wuhan, Hubei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Jiangxi province people's hospital
Nanchang, Jiangxi, China
Nanchang First Affiliated Hospital
Nanchang, Jiangxi, China
First Hospital of Affiliated of Dalian Medical University
Dalian, Liaoning, China
General Hospital of Ningxia Medical University
Yingchuan, Ningxia, China
Renji Hospital , Shanghai Jiaotong University , School of Medicine
Shanghai, Shanghai Municipality, 200127, China
Shanghai 455 Hospital
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The First Affiliated Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, China
Related Publications (1)
Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
PMID: 38899545DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
March 4, 2015
Study Start
March 26, 2014
Primary Completion
September 18, 2017
Study Completion
September 18, 2017
Last Updated
March 13, 2025
Record last verified: 2025-03