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

End-stage Renal Disease Clinical Trial

Official title:

Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05738525
• Other study ID #: S2022-775-01
• Status: Recruiting
• Start date: June 2023
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Chinese PLA General Hospital
• Contact: Xiangmei Chen
• Phone: 86-10-66935462
• Email: xmchen301[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is an observational study based on the real-word diagnosis and treatments. Target subject population include end-stage renal disease patients (aged 18-75 years) with peritoneal dialysis 3 months and longer. Standard peritoneal balance test of eligible patients should be rapid peritoneal solute transfer rate (4-hour D/P creatinine value > 0.65). Patients will be divided into two groups to receive standard APD-RPM or CAPD with a ratio of 1:2.

Peritoneal dialysis in APD-RPM group (n=250): (1) 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.

Peritoneal dialysis in CAPD group (n=500): (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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: December 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• End-stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• APD-RPM
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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint of all-cause deaths/technical failure	The time from baseline to all-cause death or technical failure	156 weeks from baseline
Primary	Quality of life (QOL)	Change of quality of life (QOL) score from the baseline	156 weeks from baseline
Primary	Returning to society	Change of assessment of returning to society from the baseline	156 weeks from baseline
Secondary	Cardio-cerebrovascular events	Incidence of cardio-cerebrovascular events, including sudden cardiac death, serious arrhythmia, coronary heart disease requiring interventional treatment, congestive heart failure with grade III and above of New York Heart Association (NYHA) classification, acute cerebral infarction, and acute cerebral hemorrhage	Up to 156 weeks
Secondary	Ultrafiltration rate	Change of ultrafiltration rate from baseline	Up to 156 weeks
Secondary	Capacity overload	Degree, proportion and frequency of capacity overload	Up to 156 weeks
Secondary	Hypertension and antihypertension drugs	Proportion of well-controlled hypertension. Quantity of antihypertension drugs	Up to 156 weeks
Secondary	Peritonitis	Proportion of peritonitis. Time to first peritonitis from enrollment	156 weeks from baseline
Secondary	Glomerular Filtration Rate	Change of slope of renal function Glomerular Filtration Rate (GFR)	Up to 156 weeks
Secondary	Nutritional status	Change of subjective global assessment (SGA) score from baseline	24, 48, 72, 96 120, 144, 156 week
Secondary	Adequacy of dialysis	Proportion of adequacy of dialysis	Up to 156 weeks
Secondary	Prescription adjustment, outpatient follow-up and unplanned outpatient visits	Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits	Up to 156 weeks
Secondary	Hospitalization	Proportion of hospitalization and unplanned hospitalization	Up to 156 weeks