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Clinical Trials in China / NCT05738525
Recruiting Observational

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

NCT05738525 · tracked via the Priya Life Science China tracker
Sponsor
Chinese PLA General Hospital
Phase
Observational
Started
2023-06
Last updated
2023-06-22

Condition(s) studied

End-stage Renal Disease

Investigational drug(s) / intervention(s)

APD-RPM

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chinese PLA General Hospital Beijing Beijing Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05738525 on ClinicalTrials.gov ↗ ← All trials in China