NCT05224466

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
25 days until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

December 14, 2021

Last Update Submit

February 3, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    within one month before the start of PD

Secondary Outcomes (1)

  • the factors that may lead to the termination of PD

    up to 20 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ESRD patients who start the PD at the first time

You may qualify if:

  • ESRD patients
  • The first time of peritoneal dialysis

You may not qualify if:

  • Age \<18 years at start of PD
  • Transfer or follow-up loss
  • Previous transplantation or HD history
  • Incomplete clinical data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200001, China

Location

Study Officials

  • Wei Fang, MD

    RenJi Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Chief Physician of Nephrology

Study Record Dates

First Submitted

December 14, 2021

First Posted

February 4, 2022

Study Start

March 1, 2022

Primary Completion

December 1, 2023

Study Completion

December 1, 2024

Last Updated

February 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations