ESRDURG-APDNCT03754361
The Study of Efficacy and Safety of Automated PD in Urgent Start Dialysis
A study testing automated peritoneal dialysis and IHD in people with ESRD, run by Peking Union Medical College Hospital at 5 sites in China.
Trial summary
This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESRD
- What is being tested?
- automated peritoneal dialysis and IHD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jan 2019to 28 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days .
- Prolonged RRT access is not available.
- No dialysis treatment was given within 1 months.
- The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization.
- Able to understand the whole process of the trial, voluntarily participate in and sign informed consent.
Who cannot join
- Maintenance RRT alraedy.
- Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours.
- Hypertensive emergencies(diastolic blood pressure>130mmHg)
- Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs.
- High catabolic state eg. severe inflammation or trauma
- Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (<1month), multiple abdominal surgeries.
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- Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure <80mmHg).
- Pregnant.
- Expected to survive for less than 1 years.
- Plan for kidney transplantation within 3 months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, 101149
Ningbo No.2 Hospital
Ningbo, Zhejiang, 315000
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: The Study of Efficacy and Safety of Automated Peritoneal Dialysis in Urgent Start Dialysis as Compared With Intermittent Hemodialysis in ESRD Patients,a Multi-center, Non-blind and Controlled Clinical Trial
This is a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.
Read the detailed description
Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialysis patient is much higher than that of regular dialysis's. So it is very important to set up dialysis pathway and from inducing dialysis into regular dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not establish the dialysis pathway in advance according to the plan. With the common, a temporary deep venous catheter would be used first, then the fistula established later, as the final transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the establishment of permanent access dialysis, simply and easily, it can protect the residual kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its unique advantages, At the same time, also avoid the temporary deep venous pathway prone to local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the future of the mature of fistula , or transplanted kidney vascular conditions. Automatic peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy and safety of urgent dialysis lacks the precisely designed multi-center, prospective and controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the safety and effectiveness of APD. Therefore, it is of great practical significance to study the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily. All patient will be monitor the physiological and biochemical marker for 14 day, and all adverse events and dead within 90days will collected to evaluated the safety, efficacy of the two urgent dialysis modes.
- Conditions
- ESRD
- Being tested
- automated peritoneal dialysis, IHD
- Keywords
- urgent start dialysis, automated PD
- 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.
automated peritoneal dialysisProcedure or surgery
peritoneal dialysis administered by a cycler
IHDProcedure or surgery
HD 4hour 2-3times per week
| Study group | Role | What they receive |
|---|---|---|
| APD group | Experimental | Subjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment Receives: Procedure: automated peritoneal dialysis |
| IHD group | Active comparator | Subjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time. Receives: Procedure: IHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
infective morbidity
peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)
Measured: At 14 days after the initiation of dialysis
Secondary outcomes (3)
Mechanical complications morbidity
catheter leakage and migration (APD), catheter obstruction (IHD)， Exit site bleeding, pneumothorax, hernia
Measured: At 14 and 90 days after the initiation of dialysis
dialysis related mortality
catheter-related:Sepsis, severe thromboembolic events (massive cerebral infarction, pulmonary embolism), arrhythmia (ventricular tachycardia, ventricular fibrillation),bleeding, Congestive heart failure and ischemic heart disease
Measured: At 14 and 90 days after the initiation of dialysis
infective morbidity
peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)
Measured: At 90 days after the initiation of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study start1 Jan 2019
- Primary completion31 Jul 2022
- Study completion28 Dec 2022
Why it stopped: Patient recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, Beijing Anzhen Hospital, The Luhe Teaching Hospital of the Capital Medical University, Ningbo No.2 Hospital
- Responsible party
- Sponsor
- Investigators
- Limeng Chen, MD, Principal investigator, Division of Nephrology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754361
- Sponsor's protocol ID
- URG-APD
- Acronym
- URG-APD
- Status last verified
- Sep 2024
- First submitted
- 15 Nov 2018
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Efficacy and Safety of Automated Peritoneal Dialysis in Urgent Start Dialysis as Compared With Intermittent Hemodialysis in ESRD Patients,a Multi-center, Non-blind and Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03754361
- Acronym / sponsor ID
- URG-APD / URG-APD
- Conditions
- ESRD
- Keywords
- urgent start dialysis, automated PD
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patient recruitment difficulties
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, Beijing Anzhen Hospital, The Luhe Teaching Hospital of the Capital Medical University, Ningbo No.2 Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 28 Dec 2022 (actual)
- First posted
- 27 Nov 2018 (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 a multi-center, controlled clinical trial study. The purpose of this study is to examine the efficacy and safety of automated peritoneal dialysis as compared with intermittent haemodialysis for ESRD patients with indications for urgent start dialysis.
Detailed description
Hemodialysis（HD） and peritoneal dialysis (PD) are both the main methods to treat with end-stage renal disease (ESRD) uremia patients. The first 3-month mortality and hospitalization rate of new dialysis patient is much higher than that of regular dialysis's. So it is very important to set up dialysis pathway and from inducing dialysis into regular dialysis smoothly. But in the global 50-70%, more than 70% of the patients in China can not establish the dialysis pathway in advance according to the plan. With the common, a temporary deep venous catheter would be used first, then the fistula established later, as the final transition for hemodialysis. Urgent peritoneal dialysis can be established 24 hours after the establishment of permanent access dialysis, simply and easily, it can protect the residual kidney function; reduce treatment costs, hemodynamic stability, no anticoagulant is its unique advantages, At the same time, also avoid the temporary deep venous pathway prone to local bleeding, infection, venous thrombosis, central venous stenosis, direct impact on the future of the mature of fistula , or transplanted kidney vascular conditions. Automatic peritoneal dialysis (APD) in the treatment of urgent dialysis patients can save more manpower and resources, and improve the efficiency of peritoneal dialysis. The study on the efficacy and safety of urgent dialysis lacks the precisely designed multi-center, prospective and controlled clinical trial, and APD only induces 3 days, it is difficult to really reflect the safety and effectiveness of APD. Therefore, it is of great practical significance to study the difference of safety, efficacy and cost-effectiveness between urgent PD and HD in a prospective, control and multicenter clinical trial. 206 ESRD uremia patients will involve in this multi-center, prospective and controlled clinical trial, the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily. All patient will be monitor the physiological and biochemical marker for 14 day, and all adverse events and dead within 90days will collected to evaluated the safety, efficacy of the two urgent dialysis modes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- the mode of urgent dialysis will choose by patient guided by nephrologist, the HD group will receive the standard traditional treatment: from induction HD to regular HD. The PD group will receive the APD daily.
| Arm | Type | Receives |
|---|---|---|
| APD group | Experimental | Procedure: automated peritoneal dialysisSubjects will receive PD catheter placement and subsequent automated peritoneal dialysis treatment |
| IHD group | Active comparator | Procedure: IHDSubjects will receive un-tunneled hemodialysis catheter placement and subsequent hemodialysis treatment 3-4 times per week,2-4 hours each time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CKD(chronic kidney disease)-5 stage patient whose eGFR（CKD-EPI（chronic kidney disease-epidemiology collaboration））<15 ml/min/1.73m2,occured uremic symptoms or volume overload need of renal replacement therapy(RRT) within 14 days .
- Prolonged RRT access is not available.
- No dialysis treatment was given within 1 months.
- The vital signs are stable and tolerable in peritoneal dialysis catheterization or central venous catheterization.
- Able to understand the whole process of the trial, voluntarily participate in and sign informed consent.
Key exclusion criteria (10 listed)
- Maintenance RRT alraedy.
- Serious metabolic disorders ( hyperkalemia and acidosis) cause significant changes in electrocardiogram or other emergency indications to RRT within 24 hours.
- Hypertensive emergencies(diastolic blood pressure>130mmHg)
- Severe respiratory, circulatory or hepatic failure requires instrumental support or vasoactive drugs to maintain vital signs.
- High catabolic state eg. severe inflammation or trauma
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 |
|---|---|---|
| automated peritoneal dialysisperitoneal dialysis administered by a cycler | Procedure or surgery | APD group |
| IHDHD 4hour 2-3times per week | Procedure or surgery | IHD group |
Primary outcome
infective morbidity
Time frame: At 14 days after the initiation of dialysis
peritonitis (APD), Bacteremia and catheter-related infections (APD and IHD)
3 secondary outcomes
Mechanical complications morbidity
Time frame: At 14 and 90 days after the initiation of dialysis
dialysis related mortality
Time frame: At 14 and 90 days after the initiation of dialysis
infective morbidity
Time frame: At 90 days after the initiation of dialysis
Results and safety
The study was stopped early (reason given: Patient recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Individual participant dataSharing planned: No. To comply with laws in China, local regulations and hospital policy, IPD sharing might be restricted
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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. This study is not recruiting at the moment.
Limeng Chen, MD principal investigator
Division of Nephrology, Peking Union Medical College Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing automated peritoneal dialysis and IHD in people with ESRD, run by Peking Union Medical College Hospital at 5 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study was stopped early (reason given: Patient recruitment difficulties). Results are not available in the source record.
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?
infective morbidity (time frame: At 14 days after the initiation of dialysis). 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 8 Jun 2025.