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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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End-stage Renal Disease

Intervention / Treatment
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* Device: APD-RPM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Automated peritoneal dialysis with remote patient management (APD-RPM)<br>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<br>* 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.<br>|
| Continuous ambulatory peritoneal dialysis (CAPD)<br>(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. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardio-cerebrovascular events | 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 | Up to 156 weeks | 
| Ultrafiltration rate | Change of ultrafiltration rate from baseline | Up to 156 weeks | 
| Capacity overload | Degree, proportion and frequency of capacity overload | Up to 156 weeks | 
| Hypertension and antihypertension drugs | Proportion of well-controlled hypertension. Quantity of antihypertension drugs | Up to 156 weeks | 
| Peritonitis | Proportion of peritonitis. Time to first peritonitis from enrollment | 156 weeks from baseline | 
| Glomerular Filtration Rate | Change of slope of renal function Glomerular Filtration Rate (GFR) | Up to 156 weeks | 
| Nutritional status | Change of subjective global assessment (SGA) score from baseline | 24, 48, 72, 96 120, 144, 156 week | 
| Adequacy of dialysis | Proportion of adequacy of dialysis | Up to 156 weeks | 
| Prescription adjustment, outpatient follow-up and unplanned outpatient visits | Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits | Up to 156 weeks | 
| Hospitalization | Proportion of hospitalization and unplanned hospitalization | Up to 156 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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APD-RPM, CAPD, Prognosis, QOL, Comparative Study