Peritoneal Dialysis (PD)NCT07798024
Effect of IRPM-APD on Clinical Outcomes for PD Patients
An observational study of Peritoneal Dialysis (PD), run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis (PD)
- What is being tested?
- Integrated remote patient monitoring (IRPM)
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2026to 31 Dec 2028
- How long will I take part?
- 24 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident APD patients of multiple centesr who meet the inclusion criteria will be recruited.
Who may be able to join
- Incident PD patients with age ≥18 years;
- For APD-IRPM group, patients preferred to use the APD machine of Homechoice Claria®；
- For Control group, patients treated with APD therapy (without RPM system) at the initiation of PD;
- Signed an informed consent form.
Who cannot join
- Peritonitis occurred within 6 weeks before the baseline assessment.
- Urinary catheter was removed or abdominal surgery was performed within 60 days before the baseline assessment.
- Patients who have severe cognitive impairment or mental illness, rendering them unable to complete the follow-up.
About this study
Official title: Impact of Integrated Remote Patient Monitoring on Clinical Outcomes for Patients With Automated Peritoneal Dialysis: a Historical Control Prospective Study
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
- Conditions
- Peritoneal Dialysis (PD)
- Being tested
- Integrated remote patient monitoring (IRPM)
- Keywords
- Peritoneal Dialysis, automated peritoneal dialysis, remote patient monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated remote patient monitoring (IRPM)Other
IRPM provided information gathered by RPM of treatment data day-by-day, and achieved higher-frequency information feedback and clinical decision support. Additionally, the current knowledge about the effects of RPM in APD limited real-world research.
| Study group | Role | What they receive |
|---|---|---|
| CON | In the APD group, the PD team did not have access to the information transmitted by the RPM device; the management of patients in the APD group was carried out in the usual way. | |
| IRPM-APD | Doctors and nurses were instructed to review daily the data provided by the IRPM-APD device for IRPM-APD arms patients. In detail, daily data includes the day and time of connection, the duration of treatment per day, total exchange volume, the number of cycles, use or not of wet day (i.e. daytime exchange in the preceding day), dialysate volume infused, total dwell time, dwell time per exchange, actual time for filling and draining per exchange, drain volume per dwell and total treatment, cycle profile, total and dwell ultrafiltration, and number of events per treatment. The number and reason for alarms, events and bypass drain were also recorded and reviewed. Receives: Other: Integrated remote patient monitoring (IRPM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite indices were constructed based on four SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) core outcomes: mortality, cardiovascular (CV) diseases, PD infection and technique survival, complemented by SONG-PD middle.
Primary endpoints were time to the first event of Composite Index, including mortality (all-cause mortality and CV-related mortality), transferring to hemodialysis (technique failure), and peritonitis.
Measured: From date of randomization until the date of first event, whichever came first, assessed at least 24 months.
Secondary outcomes (7)
Adverse events
Rate of adverse events in one year.
Measured: From date of randomization until the end of follow-up, assessed at least 24 months
Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure)
Rate of hospitalizations in one year.
Measured: From date of randomization until the end of follow-up, assessed at least 24 months
Unplanned visits, defined as any unscheduled medical contacts (including outpatient visits, emergency room visits, or phone calls) made by peritoneal dialysis patients because of unexpected health issues, beyond the routine follow-up schedule.
Rate of unplanned visits in one year.
Measured: From date of randomization until the end of follow-up, assessed at least 24 months.
Nutritional condition (evaluated by SGA)
Change of nutritional condition in one year.
Measured: From date of randomization until study completion, assessed at least 24 months.
Quality of life (evaluated by SF36)
The Short Form 36-item Health Survey (SF-36) scores range from 0 to 100, with higher scores indicating better health status and fewer limitations.
Measured: Change of quality of life in one year.
Residual renal function decline
Rate of residual renal function decline in one year.
Measured: From date of randomization until the end of follow-up, assessed at least 24 months.
Consumption of medical resources
Medical resource consumption is measured by the time of nurse reviews of remote monitoring data and alarm events.
Measured: From date of randomization until study completion, assessed at least 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis (PD)Studies 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
- Other
- Enrolment
- 600 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Chen, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798024
- Sponsor's protocol ID
- IIT-2026-535
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrated Remote Patient Monitoring on Clinical Outcomes for Patients With Automated Peritoneal Dialysis: a Historical Control Prospective Study
- ClinicalTrials.gov ID
- NCT07798024
- Acronym / sponsor ID
- IIT-2026-535
- Conditions
- Peritoneal Dialysis (PD)
- Keywords
- Peritoneal Dialysis, automated peritoneal dialysis, remote patient monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Sep 2026 (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.
To evaluate the impact of an integrated remote patient monitoring model on clinical, operational, and health-economic outcomes for patients receiving APD
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 24 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CON | – | –In the APD group, the PD team did not have access to the information transmitted by the RPM device; the management of patients in the APD group was carried out in the usual way. |
| IRPM-APD | – | Other: Integrated remote patient monitoring (IRPM)Doctors and nurses were instructed to review daily the data provided by the IRPM-APD device for IRPM-APD arms patients. In detail, daily data includes the day and time of connection, the duration of treatment per day, total exchange volume, the number of cycles, use or not of wet day (i.e. daytime exchange in the preceding day), dialysate volume infused, total dwell time, dwell time per exchange, actual time for filling and draining per exchange, drain volume per dwell and total treatment, cycle profile, total and dwell ultrafiltration, and number of events per treatment. The number and reason for alarms, events and bypass drain were also recorded and reviewed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident APD patients of multiple centesr who meet the inclusion criteria will be recruited.
Key inclusion criteria (4 listed)
- Incident PD patients with age ≥18 years;
- For APD-IRPM group, patients preferred to use the APD machine of Homechoice Claria®；
- For Control group, patients treated with APD therapy (without RPM system) at the initiation of PD;
- Signed an informed consent form.
Key exclusion criteria (3 listed)
- Peritonitis occurred within 6 weeks before the baseline assessment.
- Urinary catheter was removed or abdominal surgery was performed within 60 days before the baseline assessment.
- Patients who have severe cognitive impairment or mental illness, rendering them unable to complete the follow-up.
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 |
|---|---|---|
| Integrated remote patient monitoring (IRPM)IRPM provided information gathered by RPM of treatment data day-by-day, and achieved higher-frequency information feedback and clinical decision support. Additionally, the current knowledge about the effects of RPM in APD limited real-world research. | Other | IRPM-APD |
Primary outcome
Composite indices were constructed based on four SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) core outcomes: mortality, cardiovascular (CV) diseases, PD infection and technique survival, complemented by SONG-PD middle.
Time frame: From date of randomization until the date of first event, whichever came first, assessed at least 24 months.
Primary endpoints were time to the first event of Composite Index, including mortality (all-cause mortality and CV-related mortality), transferring to hemodialysis (technique failure), and peritonitis.
7 secondary outcomes
Adverse events
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Hospitalizations linked to adverse events possibly related to potentially preventable causes such as fluid overload (edema, hypertension and heart failure)
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months
Unplanned visits, defined as any unscheduled medical contacts (including outpatient visits, emergency room visits, or phone calls) made by peritoneal dialysis patients because of unexpected health issues, beyond the routine follow-up schedule.
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Nutritional condition (evaluated by SGA)
Time frame: From date of randomization until study completion, assessed at least 24 months.
Quality of life (evaluated by SF36)
Time frame: Change of quality of life in one year.
Residual renal function decline
Time frame: From date of randomization until the end of follow-up, assessed at least 24 months.
Consumption of medical resources
Time frame: From date of randomization until study completion, assessed at least 24 months.
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 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Dialysis (PD), run by First Affiliated Hospital, Sun Yat-Sen University.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite indices were constructed based on four SONG-PD (Standardized Outcomes in Nephrology-Peritoneal Dialysis) core outcomes: mortality, cardiovascular (CV) diseases, PD infection and technique survival, complemented by SONG-PD middle. (time frame: From date of randomization until the date of first event, whichever came first, assessed at least 24 months.). 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 1 Sep 2026.