Peritoneal Dialysis ComplicationNCT05224466
Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients
An observational study of Peritoneal Dialysis Complication, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Dialysis Complication
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2022to Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: ESRD patients who start the PD at the first time
Who may be able to join
- ESRD patients
- The first time of peritoneal dialysis
Who cannot join
- Age <18 years at start of PD
- Transfer or follow-up loss
- Previous transplantation or HD history
- Incomplete clinical data
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.
- Conditions
- Peritoneal Dialysis Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | defined as patients survived on PD for more than 10 years | |
| B | defined as patients survived on PD for 5-10 years | |
| C | defined as patients survived on PD within 5 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline clinical characteristics before PD
clinical characteristics about age,sex,comorbidities before PD,laboratory data would be aggregated from the existing record to find out the differences between the long-term PD patients and the others that may affect their clinical outcome.
Measured: within one month before the start of PD
Secondary outcomes (1)
the factors that may lead to the termination of PD
Some patients may end the PD early ,some late due to many reasons.To find out the factors that may influence survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment, the investigators collect and record the reasons for termination of PD to analyze.
Measured: up to 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study startMar 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Jiang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Fang, MD, Study director, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224466
- Sponsor's protocol ID
- PD
- Status last verified
- Feb 2022
- First submitted
- 14 Dec 2021
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics and Clinical Outcomes of Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT05224466
- Acronym / sponsor ID
- PD
- Conditions
- Peritoneal Dialysis Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Feb 2022 (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.
Peritoneal dialysis patients worldwide account for about 11% of the global dialysis population. The global annual growth rate of peritoneal dialysis is estimated to be 8%, which is listed as the preferred method of renal replacement therapy in most countries. Although peritoneal dialysis has been widely used, due to complications such as peritoneal dialysis related infection, peritoneal ultrafiltration failure and EPS, the failure rate of peritoneal dialysis technology is high, and the 3-year technical survival rate is only 64%. Therefore, this study intends to explore clinical strategies for maintaining the long-term peritoneal dialysis by analyzing the clinical characteristics of patients , as well as the differences of risk factors affecting the survival rate of peritoneal dialysis technology at different time stages of peritoneal dialysis treatment.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | –defined as patients survived on PD for more than 10 years |
| B | – | –defined as patients survived on PD for 5-10 years |
| C | – | –defined as patients survived on PD within 5 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ESRD patients who start the PD at the first time
Key inclusion criteria (2 listed)
- ESRD patients
- The first time of peritoneal dialysis
Key exclusion criteria (4 listed)
- Age <18 years at start of PD
- Transfer or follow-up loss
- Previous transplantation or HD history
- Incomplete clinical data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
baseline clinical characteristics before PD
Time frame: within one month before the start of PD
clinical characteristics about age,sex,comorbidities before PD,laboratory data would be aggregated from the existing record to find out the differences between the long-term PD patients and the others that may affect their clinical outcome.
1 secondary outcome
the factors that may lead to the termination of PD
Time frame: up to 20 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
- Individual participant dataSharing planned: No
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Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
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Sensor-based Congestion ALert for Events in Peritoneal Dialysis (SCALE-PD)
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Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
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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.
Wei Fang, MD study director
RenJi 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 Peritoneal Dialysis Complication, run by Shanghai Jiao Tong University School of Medicine 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 4 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Na Jiang, MD (+86-21-53882014, Jiangjiang198311@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline clinical characteristics before PD (time frame: within one month before the start of PD). 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 4 Feb 2022.