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

Recruiting now

Conditions studied: End-stage Renal Disease

In brief

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.

Key facts

Study ID

NCT05738525

Run by

Chinese PLA General Hospital

People needed

750

Starts

2023-06-01

Expected to finish

2026-12-01

Last updated by the study team

2023-06-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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