Longitudinal Dynamics of AT1R Antibodies in Kidney Transplant Recipients (AT1R)

January 20, 2026 updated by: Sang-Il Min, MD, PhD, Seoul National University Hospital

Longitudinal Dynamics of Angiotensin II Type 1 Receptor Antibodies Around Kidney Transplantation and Their Impact on Clinical Outcomes

This study aims to investigate the dynamics of Angiotensin II Type 1 Receptor Antibodies (AT1R-Ab) before and after kidney transplantation. The purpose is to understand how changes in AT1R-Ab levels may impact post-transplant kidney function and graft survival. Participants will include kidney transplant recipients, and their AT1R-Ab levels will be monitored over a one-year period. This research may help develop better predictive models for transplant outcomes, improving clinical decision-making for transplant physicians.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The study will be conducted as a prospective cohort study involving kidney transplant recipients. The participants will undergo monitoring of their AT1R-Ab levels at multiple time points before and after the transplantation, including 2 weeks, 3 months, and 1 year post-transplant. Data collected will include clinical information such as kidney function tests, graft survival rates, and post-transplant complications. The study will aim to correlate AT1R-Ab dynamics with clinical outcomes such as delayed graft function (DGF), graft loss, and creatinine levels.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Seoul
      • Seoul, Seoul, South Korea, 03080
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study was conducted at tertiary academic transplant center in South Korea and included kidney transplant recipients between 2016 and 2022. Eligible patients were those who had serum samples collected at pre-transplant and at 2 weeks, 3 months, and 1-year post-transplant, with a minimum follow-up of 1 year. Exclusion criteria were simultaneous multi-organ transplantation and age younger than 18 years. Among the 1,118 patients who underwent kidney transplantation during this period, 768 were excluded because they did not have at least four serum samples stored in the Seoul National University Hospital Biobank within 1 year after transplantation. Of the remaining 350 patients with four or more stored samples, 106 were excluded due to the absence of required time-point samples (pre-transplant and 2-week, 3-month, and 1-year post-transplant), and an additional 3 patients were excluded due to missing data for studied parameters. Consequently, a total of 241 patients were included.

Description

Inclusion Criteria:

Eligible patients were those who had serum samples collected at pre-transplant and at 2 weeks, 3 months, and 1-year post-transplant, with a minimum follow-up of 1 year

Exclusion Criteria:

Exclusion criteria were simultaneous multi-organ transplantation and age younger than 18 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Biopsy-Proven Acute Rejection (BPAR) within 3 years post-transplant
Time Frame: Up to 3 years post-transplant
This study evaluates biopsy-proven acute rejection (BPAR) as the primary outcome, using protocol biopsies at 2 weeks and 1 year post-transplant.
Up to 3 years post-transplant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Renal Function: Serum Creatinine and eGFR at 2 weeks, 3 months, and 1 year post-transplant
Time Frame: At 2 weeks, 3 months, and 1 year post-transplant
Secondary outcomes will include renal function, assessed by serum creatinine and eGFR at 2 weeks, 3 months, and 1 year post-transplant. The relationship between AT1R-Ab levels and renal function will be analyzed.
At 2 weeks, 3 months, and 1 year post-transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Republic of Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 20, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AT1R Antibodies in KT
  • RS-2023-KH140187 (Other Grant/Funding Number: Ministry of Health & Welfare, Republic of Korea)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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