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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06394596
Other study ID # 2022-1276
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date February 1, 2024

Study information

Verified date April 2024
Source Asan Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Kidney transplantation (KT) is the most effective treatment for end-stage renal disease, offering improved quality of life and long-term survival. However, predicting transplant survival and assessing prognostic factors is complex due to the multifaceted nature of patient variables and individualized treatments. Traditional methods have fallen short in their predictive accuracy. This study aims to develop machine learning algorithms capable of parsing extensive clinical data to identify key prognostic indicators that can potentially forecast survival rates for KT recipients. By incorporating baseline characteristics of donors and recipients, the model strives to unearth patterns linking donor and recipient profiles, thereby offering insights into modifiable factors that could influence postoperative outcomes. The goal is to provide a tool that aids clinicians in improving the prognosis and quality of life for KT recipients.


Description:

Kidney transplantation (KT) is the most effective treatment modality for end-stage renal disease (ESRD), offering patients the opportunity to ahieve improved quality of life and long-term survival. Advances in surgical techniques and immunosuppressive regimens have substantially decreased immediate postoperative complications and acute rejection episodes. Considering that KT is the most frequently performed organ transplantation, improving the longevity of transplant survival could benefit many individuals. The efficacy of KT is often gauged by graft function, which is a critical determinant of the graft's long-term survival and a key metric in evaluating transplant success. While post-transplant graft function is influenced by a spectrum of variables-from the characteristics of donors and recipients to immunosuppressive strategies-this complexity presents challenges in forecasting outcomes, particularly over the long term. Traditional methods, such as the kidney donor risk index (KDRI) and Cox regression analyses, have fallen short in their predictive accuracy. The prediction of transplant survival and the assessment of prognostic factors are complex due to the multifaceted nature of patient variables and the individualization of perioperative treatments. Yet, with the rise of machine learning and advanced computational analytics, researchers are now poised to decode the intricacies of data with clinical significance, potentially transforming patient care post-transplantation. The integration of deep learning algorithms into clinical practice in the field of transplantation is a relatively nascent area but is rapidly gaining traction. This study aims to develop machine learning algorithms capable of parsing extensive clinical data to pinpoint key prognostic indicators which can potentially forecast survival rates for KT recipients. By incorporating baseline characteristics of both donors and recipients, the present model strives to unearth patterns linking donor and recipient profiles, thereby offering insights into modifiable factors that could influence postoperative outcomes. Through this, we seek to provide a tool that aids clinicians in improving the prognosis and quality of life for KT recipients.


Recruitment information / eligibility

Status Completed
Enrollment 4077
Est. completion date February 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients who have received kidney transplantation (including multiple times of transplantation) at this hospital. - Patients who have listened to and understood a detailed explanation of this study, and have voluntarily decided to participate and provided written consent. Exclusion Criteria: - Patients who are receiving a multi-organ transplantation (e.g. simultaneous pancreas and kidney transplantation, simultaneous heart and kidney transplantation)

Study Design


Related Conditions & MeSH terms

  • Kidney Transplant Failure and Rejection

Intervention

Other:
Prognostic factors affecting graft survival
The primary outcome measured was a 5-year graft survival, defined as the absence of any need for dialysis or re-transplantation five years following the initial transplantation

Locations

Country Name City State
Korea, Republic of Asan Medical Center Seoul

Sponsors (3)

Lead Sponsor Collaborator
Sung Shin Asan Institute for Life Sciences, Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 5-year graft survival The primary outcome measured was a 5-year graft survival, defined as the absence of any need for dialysis or re-transplantation five years following the initial transplantation 5 years
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