- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07374484
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
Completed
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
Observational
Enrollment (Actual)
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
-
-
Seoul
-
Seoul, Seoul, South Korea, 03080
- Seoul National University Hospital
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-
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
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
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
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.
Collaborators
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
- Dragun D, Muller DN, Brasen JH, Fritsche L, Nieminen-Kelha M, Dechend R, Kintscher U, Rudolph B, Hoebeke J, Eckert D, Mazak I, Plehm R, Schonemann C, Unger T, Budde K, Neumayer HH, Luft FC, Wallukat G. Angiotensin II type 1-receptor activating antibodies in renal-allograft rejection. N Engl J Med. 2005 Feb 10;352(6):558-69. doi: 10.1056/NEJMoa035717.
- Viboon S, Townamchai N, Phiancharoen S, Kupatawintu P, Dhitivat V, Nathalang O. Prevalence of Antibody against Angiotensin II Type 1 Receptor (AT1R) Among Thai Kidney Transplant Patients. Transplant Proc. 2018 Jun;50(5):1310-1315. doi: 10.1016/j.transproceed.2018.03.020. Epub 2018 Mar 12.
- Kang ZY, Liu C, Liu W, Li DH. Effect of anti-angiotensin II type 1 receptor antibodies on the outcomes of kidney transplantation: a systematic review and meta-analysis. Nephrol Dial Transplant. 2022 May 25;37(6):1171-1180. doi: 10.1093/ndt/gfab344.
- Sorohan BM, Ismail G, Leca N, Tacu D, Obrisca B, Constantinescu I, Baston C, Sinescu I. Angiotensin II type 1 receptor antibodies in kidney transplantation: An evidence-based comprehensive review. Transplant Rev (Orlando). 2020 Oct;34(4):100573. doi: 10.1016/j.trre.2020.100573. Epub 2020 Sep 25.
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)
December 10, 2024
Primary Completion (Actual)
October 20, 2025
Study Completion (Actual)
December 9, 2025
Study Registration Dates
First Submitted
January 20, 2026
First Submitted That Met QC Criteria
January 20, 2026
First Posted (Actual)
January 28, 2026
Study Record Updates
Last Update Posted (Actual)
January 28, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Other Study ID 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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