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COMPLETEDPHASE4

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)

NCT02378350•Vantive Health LLC

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
•2. Male or female subjects aged 18 years or older at the time of randomization
•3. 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
•4. 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
•5. Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
•6. Subjects who are able to adhere to the study visit schedule and other protocol requirements
•7. Subjects who are able to come to HD clinics as required by the protocol
•8. Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks
•9. Subjects who have normal liver function, as judged by the Investigator
•10. 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

Exclusion Criteria

•1. Subjects who are HIV positive
•2. 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
•3. 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
•4. 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
•5. Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
•6. Subjects who are currently using any investigational drug
•7. Subjects who are currently enrolled in other clinical studies
•8. Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
•* 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
+3 more criteria

Locations (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, 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

Key Dates

Start Date

March 26, 2014

Primary Completion Date

September 18, 2017

Completion Date

September 18, 2017

Last Updated

March 13, 2025

Enrollment

668

ACTUAL participants

Conditions

End Stage Renal Disease

Interventions

Hemodialysis treatment (no specific device is defined)

DEVICE

Peritoneal Dialysis treatment (no specific drug is defined)

DRUG

EndoForce Post Approval Study

NCT07146854

End Stage Renal Disease (ESRD)

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RECRUITINGNA

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

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End Stage Renal DiseaseHypertension+2 more

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

Inclusion Criteria

Exclusion Criteria

EndoForce Post Approval Study

Blood Pressure Slopes and Ultrafiltration in Hemodialysis Patients

Safety & Efficacy of DCR-PHXC in Patients With PH1 and ESRD

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