Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
Sponsor study identifier
observational
750
1 country
1
Study Start
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 9, 2023
Actual (reported)February 22, 2023
Actual (reported)June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Composite endpoint of all-cause deaths/technical failure
The time from baseline to all-cause death or technical failure
156 weeks from baseline
Quality of life (QOL)
Change of quality of life (QOL) score from the baseline
156 weeks from baseline
Returning to society
Change of assessment of returning to society from the baseline
156 weeks from baseline
Cardio-cerebrovascular events
Up to 156 weeks
Ultrafiltration rate
Up to 156 weeks
Capacity overload
Up to 156 weeks
Hypertension and antihypertension drugs
Up to 156 weeks
Peritonitis
156 weeks from baseline
APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD). Dialysis dose ranges from 5 to 10 liters per day and glucose concentration starts from low concentration (1.5%).
(1) Dialysis dose ranges from 5 to 10 liters per day at the run-in period. For those with regular peritoneal dialysis, the original dose can be used according to the volume status and solute clearance effect in the past 3 months; (2) Exchange time and abdominal retention time is generally 2-5 times and 1 time at daytime and night, separately; (3) Glucose concentration includes 1.5%, 2.5% or 4.25%; (4) The treatments can be adjusted according to the change of residual renal function, peritoneal transport characteristics, volume status, solute clearance, clinical status and peritonitis.
APD mode is recommended but not limited to continuous circulating peritoneal dialysis (CCPD); (2) Dialysis dose ranges from 5 to 10 liters per day and depends on previous APD prescription and dialysis adequacy; (3) Glucose concentration starts from low concentration (1.5%) and depends on previous dialysis prescription. Remote monitoring includes dynamic changes of the overall treatment situation, warning or any abnormal notes, and drainage, retention and duration of APD per day.
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750 patients with end-stage renal disease
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Xiangmei Chen
Chinese PLA General Hospital
First Submitted
February 9, 2023
First Posted
February 22, 2023
Study Start
June 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Effects of Hemodialysis Plus Hemoperfusion in Maintenance Hemodialysis Patients: A Clinical Study
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
Contact the study team to confirm eligibility.
September 2026
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 22, 2023
Record last verified: 2023-06
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Source: ClinicalTrials.gov.
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