Comparative Study of Prognosis and QOL Between APD-RPM and CAPD

NCT05738525 | Recruiting DMC

• 1 other identifier: S2022-775-01
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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.

Conditions

End-stage Renal Disease

Keywords

APD-RPM; CAPD; Prognosis; QOL; Comparative Study

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (10)

• 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

Study Arms (2)

Automated peritoneal dialysis with remote patient management (APD-RPM)

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%).

Device: APD-RPM

Continuous ambulatory peritoneal dialysis (CAPD)

(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.

Interventions

APD-RPM DEVICE

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.

Automated peritoneal dialysis with remote patient management (APD-RPM)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

750 patients with end-stage renal disease

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xiangmei Chen

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangmei Chen

CONTACT

86-10-66935462; xmchen301@126.com

Jianhui Zhou

CONTACT

86-10-66937011; china_pd@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Chief physician, Academician of Chinese Academy of Engineering

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: February 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)