Clinical trial NCT02378350: Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
Official title: A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-03-04
Enrollment: 668
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
timeFrame: 1 year
Secondary outcomes:
measure: Mortality rates
timeFrame: 1 year
measure: Switch (PD to HD or HD to PD)
timeFrame: 1 year
measure: Transplantation rate
timeFrame: 1 year
measure: Cause of death
timeFrame: 1 year
measure: Dialysis adequacy
timeFrame: 1 year
measure: 24-hour urine volume
timeFrame: 1 year
measure: Change in hemoglobin
timeFrame: 1 year
measure: Change in serum albumin
timeFrame: 1 year
measure: Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
timeFrame: 1 year
measure: Change in S-phosphate levels
timeFrame: 1 year
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital , Sun Yet-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Panyu Central Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The Third Hospital of Sun Yat-Sen University
state: Guangdong
city: Shenzhen
country: China
facility: The 2nd Shenzhen Municipal People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Province People's Hospital
state: Guizhou
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Wuhan
country: China
facility: Traditional Chinese Medicine Hospital of Wuhan
state: Hubei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi province people's hospital
state: Jiangxi
city: Nanchang
country: China
facility: Nanchang First Affiliated Hospital
state: Jiangxi
city: Dalian
country: China
facility: First Hospital of Affiliated of Dalian Medical University
state: Liaoning
city: Yingchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Shanghai
country: China
facility: Renji Hospital , Shanghai Jiaotong University , School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai 455 Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Xinhua Hospital
state: Shanghai
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
state: Sichuan
city: Tianjin
country: China
facility: The First Affiliated Hospital of Tianjin University of TCM
state: Tianjin
Study officials:
References: