Renal Function Prediction in Living Donor Transplant Usin... | NCT06728995

Studies
Renal Function Prediction in Living Donor Transplant Using Baseline Data

NCT06728995

Sponsor

Seoul National University Hospital

Status

Active, not recruiting

Last Update Posted

Dec 11, 2024Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Renal Transplanted Recipients
Kidney Function

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
H-2205-051-1322	Other Identifier	Seoul National University Hospital Institutional Review Board

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 17, 2022Actual

Primary Completion Date

Dec 20, 2024Estimated

Completion Date

Apr 24, 2025Estimated

First Submitted Date

Dec 4, 2024

First Submission Date that Met QC Criteria

Dec 6, 2024

First Posted Date

Dec 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 6, 2024

Last Update Posted Date

Dec 11, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lowest Serum Creatinine Level	Measurement of the lowest serum creatinine level post-transplant to evaluate kidney function.	Within one year post-transplant.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Recipients and donors of living-donor kidney transplantation.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided