Renal Transplanted RecipientsNCT06728995
Renal Function Prediction in Living Donor Transplant Using Baseline Data
An observational study of Renal Transplanted Recipients and Kidney Function, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Transplanted Recipients, Kidney Function
- How many people
- 3,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 May 2022to 24 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Recipients and donors of living-donor kidney transplantation.
Who cannot join
- Donors or recipients with follow-up durations of less than 1 year.
- Recipients who received simultaneous organ transplantation in addition to kidney transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Recipient Renal Function in Living Donor Kidney Transplantation Using Baseline Characteristics and Donor Renal Volume
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
- Conditions
- Renal Transplanted Recipients, Kidney Function
- Keywords
- renal transplantation, kidney volume, predictive model, machine learning
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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lowest Serum Creatinine Level
Measurement of the lowest serum creatinine level post-transplant to evaluate kidney function.
Measured: Within one year post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start17 May 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion24 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Transplanted RecipientsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang-Il Min, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728995
- Sponsor's protocol ID
- SNUH-Volumetry_KT Recipient
- Other IDs
- H-2205-051-1322
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data will be made available to researchers upon reasonable request, subject to approval by the IRB
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Recipient Renal Function in Living Donor Kidney Transplantation Using Baseline Characteristics and Donor Renal Volume
- ClinicalTrials.gov ID
- NCT06728995
- Acronym / sponsor ID
- SNUH-Volumetry_KT Recipient
- Conditions
- Renal Transplanted Recipients, Kidney Function
- Keywords
- renal transplantation, kidney volume, predictive model, machine learning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 24 Apr 2025 (estimated)
- First posted
- 11 Dec 2024 (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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Recipients and donors of living-donor kidney transplantation.
Key exclusion criteria (2 listed)
- Donors or recipients with follow-up durations of less than 1 year.
- Recipients who received simultaneous organ transplantation in addition to kidney transplantation.
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
Lowest Serum Creatinine Level
Time frame: Within one year post-transplant.
Measurement of the lowest serum creatinine level post-transplant to evaluate kidney function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Individual participant dataSharing planned: Yes. De-identified participant data will be made available to researchers upon reasonable request, subject to approval by the IRB
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Transplanted Recipients and Kidney Function, run by Seoul National University Hospital at 1 site in South Korea.
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 1 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 11 Dec 2024. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lowest Serum Creatinine Level (time frame: Within one year post-transplant.). 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 11 Dec 2024; AzTrials last refreshed its copy on 27 Oct 2026.