NCT05738525Recruiting
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
Source: ClinicalTrials.gov · Last updated 22 Jun 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 750 (estimated)
- First submitted
- 9 Feb 2023
- Start date
- Jun 2023
- Primary completion date
- Sept 2026
- Lead sponsor
- Chinese PLA General Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT05738525
What you commit to
- Study type: Observational
- Planned participants: 750
- From Jun 2023 to the primary completion date, Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prepare for kidney transplantation within 3 years
Other illness
- 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.
- Active or treated residual malignant tumors, HIV infection
- History of alcohol or drug (illegal drugs) abuse
- Unable to continue CAPD due to ultrafiltration failure
- Mental retardation or mental illness
Lab values
- Complicated with serious liver diseases, such as cirrhosis or acute liver injury \[Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) 2 times greater the the normal\]
Age
- Pregnant or lactating women at childbearing age who disagree to use effective contraceptives during the trial
Other
- Need combined treatment of hemodialysis
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chinese PLA General Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.