Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

Chinese PLA General Hospital (301 Hospital)

Status: Enrolling

Conditions: End-stage Renal Disease

Treatments: Device: APD-RPM

Study type: Observational

Funder types: Other

Identifiers

NCT05738525

S2022-775-01

Details and patient eligibility

About

This is an observational, multicenter, parallel control study, planning to enroll 750 eligible patients to receive automated peritoneal dialysis with remote patient management (APD-RPM) and continuous ambulatory peritoneal dialysis (CAPD). Patients will attend follow-up every 12 ± 1 weeks for a total of 156 weeks. This study aims to compare the effects of APD-RPM and CAPD treatment on the prognosis and quality of life.

Full description

This is an observational study based on the real-word diagnosis and treatments. Target subject population include end-stage renal disease patients (aged 18-75 years) with peritoneal dialysis 3 months and longer. Standard peritoneal balance test of eligible patients should be rapid peritoneal solute transfer rate (4-hour D/P creatinine value > 0.65). Patients will be divided into two groups to receive standard APD-RPM or CAPD with a ratio of 1:2.

Peritoneal dialysis in APD-RPM group (n=250): (1) APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD); (2) Dialysis dose ranges from 5 to 10 liters per day and depends on previous APD prescription and dialysis adequacy; (3) Glucose concentration starts from low concentration (1.5%) and depends on previous dialysis prescription.

Peritoneal dialysis in CAPD group (n=500): (1) Dialysis dose ranges from 5 to 10 liters per day at the run-in period. For those with regular peritoneal dialysis, the original dose can be used according to the volume status and solute clearance effect in the past 3 months; (2) Exchange time and abdominal retention time is generally 2-5 times and 1 time at daytime and night, separately; (3) Glucose concentration includes 1.5%, 2.5% or 4.25%; (4) The treatments can be adjusted according to the change of residual renal function, peritoneal transport characteristics, volume status, solute clearance, clinical status and peritonitis.

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18 years to 75 years
• Confirmed diagnosis of end-stage renal disease
• Standard peritoneal balance test shows rapid peritoneal solute transfer rate, defined as 4 hours D/P creatinine value greater than 0.65
• Be able to comply with the standard peritoneal dialysis treatment at home
• Peritoneal dialysis time 3 months and longer
• Fully understand the study and have signed the informed consent

Exclusion criteria

• Prepare for kidney transplantation within 3 years
• Need combined treatment of hemodialysis
• Be allergic to components of peritoneal dialysis fluid
• Complicated with severe cardio-cerebrovascular diseases such as congestive heart failure, grade III and above of NYHA classification, acute myocardial infarction within 3 months, malignant arrhythmia requiring treatment, dilated cardiomyopathy, acute cerebral infarction or acute cerebral hemorrhage within 3 months, etc.
• Complicated with serious liver diseases, such as cirrhosis or acute liver injury [Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) 2 times greater the the normal]
• Active or treated residual malignant tumors, HIV infection
• Pregnant or lactating women at childbearing age who disagree to use effective contraceptives during the trial
• History of alcohol or drug (illegal drugs) abuse
• Unable to continue CAPD due to ultrafiltration failure
• Mental retardation or mental illness
• Patients who use icodextrin dialysate
• Participation in other clinical trials in the past 3 months
• Peritonitis in the past 3 months
• Other situations decided by the investigator

Trial design

750 participants in 2 patient groups

Automated peritoneal dialysis with remote patient management (APD-RPM)

Description:

APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD). Dialysis dose ranges from 5 to 10 liters per day and glucose concentration starts from low concentration (1.5%).

Treatment:

Device: APD-RPM

Continuous ambulatory peritoneal dialysis (CAPD)

Description:

(1) Dialysis dose ranges from 5 to 10 liters per day at the run-in period. For those with regular peritoneal dialysis, the original dose can be used according to the volume status and solute clearance effect in the past 3 months; (2) Exchange time and abdominal retention time is generally 2-5 times and 1 time at daytime and night, separately; (3) Glucose concentration includes 1.5%, 2.5% or 4.25%; (4) The treatments can be adjusted according to the change of residual renal function, peritoneal transport characteristics, volume status, solute clearance, clinical status and peritonitis.