Kidney TransplantationAT1RNCT07374484
Longitudinal Dynamics of AT1R Antibodies in Kidney Transplant Recipients
An observational study of Kidney Transplantation and Graft Survival, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplantation, Graft Survival, Angiotensin II Type 1 Receptor Antibody
- How many people
- 241 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Dec 2024to 9 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Exclusion criteria were simultaneous multi-organ transplantation and age younger than 18 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Keywords
- Angiotensin II Type 1 Receptor Antibody, Kidney Transplantation, Graft Survival
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy-Proven Acute Rejection (BPAR) within 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.
Measured: Up to 3 years post-transplant
Secondary outcomes (1)
Renal Function: Serum Creatinine and eGFR 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.
Measured: At 2 weeks, 3 months, and 1 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 posted28 Jan 2026
- Study start10 Dec 2024
- Primary completion20 Oct 2025
- Study completion9 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies 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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, Sang-Il Min, MD, PhD, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07374484
- Sponsor's protocol ID
- AT1R Antibodies in KT
- Other IDs
- RS-2023-KH140187
- Acronym
- AT1R
- Status last verified
- Jan 2026
- First submitted
- 20 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15703421Viboon 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.
PubMed 29880351Kang 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.
PubMed 34865146Sorohan 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.
PubMed 33002671
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Dynamics of Angiotensin II Type 1 Receptor Antibodies Around Kidney Transplantation and Their Impact on Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07374484
- Acronym / sponsor ID
- AT1R / AT1R Antibodies in KT
- Keywords
- Angiotensin II Type 1 Receptor Antibody, Kidney Transplantation, Graft Survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, Republic of Korea
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 9 Dec 2025 (actual)
- First posted
- 28 Jan 2026 (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 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Exclusion criteria were simultaneous multi-organ transplantation and age younger than 18 years.
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
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Background: PubMed 15703421Dragun 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.
- Background: PubMed 29880351Viboon 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.
- Background: PubMed 34865146Kang 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.
- Background: PubMed 33002671Sorohan 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.
- Individual participant dataSharing planned: No
Related trials for Kidney Transplantation
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
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 Kidney Transplantation and Graft Survival, 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 1 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: finished, as of the sponsor's last update on 28 Jan 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biopsy-Proven Acute Rejection (BPAR) within 3 years post-transplant (time frame: Up to 3 years post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07374484, which also lists 4 linked publications.
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 28 Jan 2026.