- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05738525
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
Comparative Study of Automated Peritoneal Dialysis With Remote Patient Management And Continuous Ambulatory Peritoneal Dialysis on the Prognosis and QOL in Peritoneal Dialysis Patients
Study Overview
Detailed 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Xiangmei Chen
- Phone Number: 86-10-66935462
- Email: xmchen301@126.com
Study Contact Backup
- Name: Jianhui Zhou
- Phone Number: 86-10-66937011
- Email: china_pd@126.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Jianhui Zhou
- Phone Number: 86-10-66937011
- Email: china_pd@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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%).
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
156 weeks from baseline
|
Quality of life (QOL)
Time Frame: 156 weeks from baseline
|
Change of quality of life (QOL) score from the baseline
|
156 weeks from baseline
|
Returning to society
Time Frame: 156 weeks from baseline
|
Change of assessment of returning to society from the baseline
|
156 weeks from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Up to 156 weeks
|
Ultrafiltration rate
Time Frame: Up to 156 weeks
|
Change of ultrafiltration rate from baseline
|
Up to 156 weeks
|
Capacity overload
Time Frame: Up to 156 weeks
|
Degree, proportion and frequency of capacity overload
|
Up to 156 weeks
|
Hypertension and antihypertension drugs
Time Frame: Up to 156 weeks
|
Proportion of well-controlled hypertension.
Quantity of antihypertension drugs
|
Up to 156 weeks
|
Peritonitis
Time Frame: 156 weeks from baseline
|
Proportion of peritonitis.
Time to first peritonitis from enrollment
|
156 weeks from baseline
|
Glomerular Filtration Rate
Time Frame: Up to 156 weeks
|
Change of slope of renal function Glomerular Filtration Rate (GFR)
|
Up to 156 weeks
|
Nutritional status
Time Frame: 24, 48, 72, 96 120, 144, 156 week
|
Change of subjective global assessment (SGA) score from baseline
|
24, 48, 72, 96 120, 144, 156 week
|
Adequacy of dialysis
Time Frame: Up to 156 weeks
|
Proportion of adequacy of dialysis
|
Up to 156 weeks
|
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
|
Up to 156 weeks
|
Hospitalization
Time Frame: Up to 156 weeks
|
Proportion of hospitalization and unplanned hospitalization
|
Up to 156 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiangmei Chen, Chinese PLA General Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2022-775-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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