Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
Recruiting · NCT05738525 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chinese PLA General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
APD-RPM
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Chinese PLA General Hospital - Beijing, Beijing Municipality, China