NCT05738525 Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
| NCT ID | NCT05738525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese PLA General Hospital |
| Condition | End-stage Renal Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 750 participants |
| Start Date | 2023-06 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 750 participants in total. It began in 2023-06 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Xiangmei Chen
PRINCIPAL INVESTIGATOR
Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT05738525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying End-stage Renal Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05738525 currently recruiting?
Yes, NCT05738525 is actively recruiting participants. Contact the research team at xmchen301@126.com for enrollment information.
Where is the NCT05738525 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05738525 clinical trial?
NCT05738525 is sponsored by Chinese PLA General Hospital. The principal investigator is Xiangmei Chen at Chinese PLA General Hospital. The trial plans to enroll 750 participants.