End-stage Renal DiseaseNCT05738525
Comparative Study of Prognosis and QOL Between APD-RPM and CAPD
An observational study of End-stage Renal Disease, run by Chinese PLA General Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- APD-RPM
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- Jun 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 750 patients with end-stage renal disease
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Jianhui Zhou, 86-10-66937011, china_pd@126.com
About this study
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
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- APD-RPM
- Keywords
- APD-RPM, CAPD, Prognosis, QOL, Comparative Study
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APD-RPMDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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%). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite endpoint of all-cause deaths/technical failure
The time from baseline to all-cause death or technical failure
Measured: 156 weeks from baseline
Quality of life (QOL)
Change of quality of life (QOL) score from the baseline
Measured: 156 weeks from baseline
Returning to society
Change of assessment of returning to society from the baseline
Measured: 156 weeks from baseline
Secondary outcomes (10)
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
Measured: Up to 156 weeks
Ultrafiltration rate
Change of ultrafiltration rate from baseline
Measured: Up to 156 weeks
Capacity overload
Degree, proportion and frequency of capacity overload
Measured: Up to 156 weeks
Hypertension and antihypertension drugs
Proportion of well-controlled hypertension. Quantity of antihypertension drugs
Measured: Up to 156 weeks
Peritonitis
Proportion of peritonitis. Time to first peritonitis from enrollment
Measured: 156 weeks from baseline
Glomerular Filtration Rate
Change of slope of renal function Glomerular Filtration Rate (GFR)
Measured: Up to 156 weeks
Nutritional status
Change of subjective global assessment (SGA) score from baseline
Measured: 24, 48, 72, 96 120, 144, 156 week
Adequacy of dialysis
Proportion of adequacy of dialysis
Measured: Up to 156 weeks
Prescription adjustment, outpatient follow-up and unplanned outpatient visits
Times of prescription adjustment, outpatient follow-up and unplanned outpatient visits
Measured: Up to 156 weeks
Hospitalization
Proportion of hospitalization and unplanned hospitalization
Measured: Up to 156 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startJun 2023 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- Xiangmei Chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05738525
- Sponsor's protocol ID
- S2022-775-01
- Status last verified
- Jun 2023
- First submitted
- 9 Feb 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05738525
- Acronym / sponsor ID
- S2022-775-01
- Conditions
- End-stage Renal Disease
- Keywords
- APD-RPM, CAPD, Prognosis, QOL, Comparative Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated peritoneal dialysis with remote patient management (APD-RPM) | – | Device: APD-RPMAPD 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%). |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 750 patients with end-stage renal disease
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APD-RPMAPD 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. | Device | Automated peritoneal dialysis with remote patient management (APD-RPM) |
Primary outcome
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
Quality of life (QOL)
Time frame: 156 weeks from baseline
Change of quality of life (QOL) score from the baseline
Returning to society
Time frame: 156 weeks from baseline
Change of assessment of returning to society from the baseline
10 secondary outcomes
Cardio-cerebrovascular events
Time frame: Up to 156 weeks
Ultrafiltration rate
Time frame: Up to 156 weeks
Capacity overload
Time frame: Up to 156 weeks
Hypertension and antihypertension drugs
Time frame: Up to 156 weeks
Peritonitis
Time frame: 156 weeks from baseline
Glomerular Filtration Rate
Time frame: Up to 156 weeks
Nutritional status
Time frame: 24, 48, 72, 96 120, 144, 156 week
Adequacy of dialysis
Time frame: Up to 156 weeks
Prescription adjustment, outpatient follow-up and unplanned outpatient visits
Time frame: Up to 156 weeks
Hospitalization
Time frame: Up to 156 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangmei Chen principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End-stage Renal Disease, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangmei Chen (86-10-66935462, xmchen301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite endpoint of all-cause deaths/technical failure (time frame: 156 weeks from baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023; AzTrials last refreshed its copy on 26 Oct 2026.