Clinical trial NCT05738525: Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: End-stage Renal Disease
Keywords: APD-RPM
CAPD
Prognosis
QOL
Comparative Study
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 750 patients with end-stage renal disease

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint of all-cause deaths/technical failure
timeFrame: 156 weeks from baseline
measure: Quality of life (QOL)
timeFrame: 156 weeks from baseline
measure: Returning to society
timeFrame: 156 weeks from baseline
Secondary outcomes:
measure: Cardio-cerebrovascular events
timeFrame: Up to 156 weeks
measure: Ultrafiltration rate
timeFrame: Up to 156 weeks
measure: Capacity overload
timeFrame: Up to 156 weeks
measure: Hypertension and antihypertension drugs
timeFrame: Up to 156 weeks
measure: Peritonitis
timeFrame: 156 weeks from baseline
measure: Glomerular Filtration Rate
timeFrame: Up to 156 weeks
measure: Nutritional status
timeFrame: 24, 48, 72, 96 120, 144, 156 week
measure: Adequacy of dialysis
timeFrame: Up to 156 weeks
measure: Prescription adjustment, outpatient follow-up and unplanned outpatient visits
timeFrame: Up to 156 weeks
measure: Hospitalization
timeFrame: Up to 156 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Xiangmei Chen
role: PRINCIPAL_INVESTIGATOR
References: