Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China

End Stage Renal Disease Clinical Trial

Official title:

A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378350
• Other study ID #: 8339-001
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2015
• Last updated: October 18, 2017
• Start date: March 26, 2014
• Est. completion date: September 18, 2017

Study information

• Verified date: October 2017
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: September 18, 2017
• Est. primary completion date: September 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• Hemodialysis treatment (no specific device is defined)

Drug:
• Peritoneal Dialysis treatment (no specific drug is defined)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire		1 year
Secondary	Mortality rates		1 year
Secondary	Switch (PD to HD or HD to PD)		1 year
Secondary	Transplantation rate		1 year
Secondary	Cause of death		1 year
Secondary	Dialysis adequacy		1 year
Secondary	24-hour urine volume		1 year
Secondary	Change in hemoglobin		1 year
Secondary	Change in serum albumin		1 year
Secondary	Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance		1 year
Secondary	Change in S-phosphate levels		1 year