Comparing automated peritoneal dialysis with remote management to standard peritoneal dialysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to enroll 750 patients with end-stage renal disease to compare the prognosis and quality of life outcomes between two types of peritoneal dialysis: automated peritoneal dialysis with remote patient management (APD-RPM) and continuous ambulatory peritoneal dialysis (CAPD). Participants will be followed for a total of 156 weeks, attending follow-up visits every 12 weeks. The study will assess the effectiveness of these two treatment approaches based on real-world data and patient experiences.

Why it matters

Who can join: the full rules

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's running

• Chinese PLA General Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Xiangmei Chen — Chinese PLA General Hospital
• Study coordinator: Xiangmei Chen
• Email: xmchen301@126.com
• Phone: 86-10-66935462

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.