Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
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
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