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)

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

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: Hemodialysis treatment (no specific device is defined); Drug: Peritoneal Dialysis treatment (no specific drug is defined)

• Study Type: Interventional
• Enrollment (Actual): 668
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
  • Gansu
    • Lanzhou, Gansu, China
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • The Third Hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital , Sun Yet-Sen University
    • Guangzhou City, Guangdong, China
      • Guangzhou Panyu Central Hospital
    • Shenzhen, Guangdong, China
      • The 2nd Shenzhen Municipal People's Hospital
  • Guizhou
    • Gui Yang City, Guizhou, China
      • GuiZhou Province People's Hospital
  • Heilongjiang
    • Harbin City, Heilongjiang, China
      • The Second Affiliated Hospital of Harbin Medical University
  • Hubei
    • Wuhan City, Hubei, China
      • Traditional Chinese Medicine Hospital of Wuhan
  • Hunan
    • Changsha, Hunan, China
      • The Third Xiangya Hospital of Central South University
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi province people's hospital
    • Nangchang, Jiangxi, China
      • Nanchang First Affiliated Hospital
  • Liaoning
    • Dalian, Liaoning, China
      • First Hospital of Affiliated of Dalian Medical University
  • Ningxia
    • Yingchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Xinhua hospital
    • Shanghai, Shanghai, China
      • Shanghai Tenth People's Hospital
    • Shanghai, Shanghai, China, 200127
      • Renji Hospital , Shanghai Jiaotong University , School of Medicine
    • Shanghai, Shanghai, China
      • Shanghai 455 Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • Sichuan Provincial People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • The First Affiliated Hospital of Tianjin University of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

9. 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
10. Subjects who have a malignancy requiring chemotherapy or radiation therapy
11. Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
12. Subjects who have a life expectancy of < 48 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: ESRD patients receiving HD treatment; no investigational drug involved. Only observe therapy treatment	Device: Hemodialysis treatment (no specific device is defined)
Experimental: ESRD patients receiving PD treatment; no investigational drug involved. Only observe therapy treatment	Drug: Peritoneal Dialysis treatment (no specific drug is defined)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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
24-hour urine volume	1 year
Change in hemoglobin	1 year
Change in serum albumin	1 year
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance	1 year
Change in S-phosphate levels	1 year

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2014
• Primary Completion (Actual): September 18, 2017
• Study Completion (Actual): September 18, 2017

Study Registration Dates

• First Submitted: February 10, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (Estimate): March 4, 2015

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 18, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 8339-001