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

Sponsor

Chinese PLA General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05738525

Collaborator

(none)

750

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
End-stage Renal Disease	Device: APD-RPM

Detailed 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

750 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Automated peritoneal dialysis with remote patient management (APD-RPM) 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%).	Device: APD-RPM 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. Remote monitoring includes dynamic changes of the overall treatment situation, warning or any abnormal notes, and drainage, retention and duration of APD per day.
Continuous ambulatory peritoneal dialysis (CAPD) (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.

Arm

Intervention/Treatment

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

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%).

Device: APD-RPM

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. Remote monitoring includes dynamic changes of the overall treatment situation, warning or any abnormal notes, and drainage, retention and duration of APD per day.

Continuous ambulatory peritoneal dialysis (CAPD)

(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.

Outcome Measures

Primary Outcome Measures

Composite endpoint of all-cause deaths/technical failure [156 weeks from baseline]
The time from baseline to all-cause death or technical failure
Quality of life (QOL) [156 weeks from baseline]
Change of quality of life (QOL) score from the baseline
Returning to society [156 weeks from baseline]
Change of assessment of returning to society from the baseline

Secondary Outcome Measures

Cardio-cerebrovascular events [Up to 156 weeks]
Incidence of cardio-cerebrovascular events, including sudden cardiac death, serious arrhythmia, coronary heart disease requiring interventional treatment, congestive heart failure with grade III and above of New York Heart Association (NYHA) classification, acute cerebral infarction, and acute cerebral hemorrhage
Ultrafiltration rate [Up to 156 weeks]
Change of ultrafiltration rate from baseline
Capacity overload [Up to 156 weeks]
Degree, proportion and frequency of capacity overload
Hypertension and antihypertension drugs [Up to 156 weeks]
Proportion of well-controlled hypertension. Quantity of antihypertension drugs
Peritonitis [156 weeks from baseline]
Proportion of peritonitis. Time to first peritonitis from enrollment
Glomerular Filtration Rate [Up to 156 weeks]
Change of slope of renal function Glomerular Filtration Rate (GFR)
Nutritional status [24, 48, 72, 96 120, 144, 156 week]
Change of subjective global assessment (SGA) score from baseline
Adequacy of dialysis [Up to 156 weeks]
Proportion of adequacy of dialysis
Prescription adjustment, outpatient follow-up and unplanned outpatient visits [Up to 156 weeks]
Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits
Hospitalization [Up to 156 weeks]
Proportion of hospitalization and unplanned hospitalization

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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