NCT06728995

Brief Summary

This study aims to predict early post-transplant kidney function in living donor kidney transplant recipients using baseline characteristics of donors and recipients. The study involves analyzing pre-transplant data to develop a machine learning model that predicts serum creatinine levels one year post-transplant. This research may improve decision-making and outcomes for transplant patients

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

December 4, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2025

Completed
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

2.6 years

First QC Date

December 4, 2024

Last Update Submit

December 6, 2024

Conditions

Keywords

renal transplantationkidney volumepredictive modelmachine learning

Outcome Measures

Primary Outcomes (1)

  • Lowest Serum Creatinine Level

    Measurement of the lowest serum creatinine level post-transplant to evaluate kidney function.

    Within one year post-transplant.

Study Arms (1)

Study Population

All participants included in the retrospective study who underwent living-donor kidney transplantation. No interventions were applied as this is an observational study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants were recruited from Seoul National University Hospital, Severance Hospital, and Bundang Seoul National University Hospital, encompassing recipients and donors involved in living-donor kidney transplantation.

You may qualify if:

  • \- Recipients and donors of living-donor kidney transplantation.

You may not qualify if:

  • Donors or recipients with follow-up durations of less than 1 year.
  • Recipients who received simultaneous organ transplantation in addition to kidney transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 4, 2024

First Posted

December 11, 2024

Study Start

May 17, 2022

Primary Completion

December 20, 2024

Study Completion

April 24, 2025

Last Updated

December 11, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will share

De-identified participant data will be made available to researchers upon reasonable request, subject to approval by the IRB

Locations