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NCT Number: NCT05738525

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Jianhui Zhou

CONTACT

[email protected]

86-10-66937011

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Composite endpoint of all-cause deaths/technical failure

    Time frame: 156 weeks from baseline

    The time from baseline to all-cause death or technical failure

  2. Quality of life (QOL)

    Time frame: 156 weeks from baseline

    Change of quality of life (QOL) score from the baseline

  3. Returning to society

    Time frame: 156 weeks from baseline

    Change of assessment of returning to society from the baseline

Secondary outcomes

  1. Cardio-cerebrovascular events

    Time frame: Up to 156 weeks

    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

  2. Ultrafiltration rate

    Time frame: Up to 156 weeks

    Change of ultrafiltration rate from baseline

  3. Capacity overload

    Time frame: Up to 156 weeks

    Degree, proportion and frequency of capacity overload

  4. Hypertension and antihypertension drugs

    Time frame: Up to 156 weeks

    Proportion of well-controlled hypertension. Quantity of antihypertension drugs

  5. Peritonitis

    Time frame: 156 weeks from baseline

    Proportion of peritonitis. Time to first peritonitis from enrollment

  6. Glomerular Filtration Rate

    Time frame: Up to 156 weeks

    Change of slope of renal function Glomerular Filtration Rate (GFR)

  7. Nutritional status

    Time frame: 24, 48, 72, 96 120, 144, 156 week

    Change of subjective global assessment (SGA) score from baseline

  8. Adequacy of dialysis

    Time frame: Up to 156 weeks

    Proportion of adequacy of dialysis

  9. Prescription adjustment, outpatient follow-up and unplanned outpatient visits

    Time frame: Up to 156 weeks

    Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits

  10. Hospitalization

    Time frame: Up to 156 weeks

    Proportion of hospitalization and unplanned hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Jianhui Zhou

CONTACT

[email protected]

86-10-66937011

Xiangmei Chen

CONTACT

[email protected]

86-10-66935462

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 22, 2023
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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