Longitudinal Dynamics of AT1R Antibodies in Kidney Transplant Recipients

NCT07374484 | Completed

• 2 other identifiers: AT1R Antibodies in KTRS-2023-KH140187
• Study Type: observational
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Kidney Transplantation; Graft Survival; Angiotensin II Type 1 Receptor Antibody

Keywords

Angiotensin II Type 1 Receptor Antibody; Kidney Transplantation; Graft Survival

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At 2 weeks, 3 months, and 1 year post-transplant

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Health, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Publications (4)

• 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.

  PMID: 15703421 BACKGROUND

• 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.

  PMID: 29880351 BACKGROUND

• 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.

  PMID: 34865146 BACKGROUND

• 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.

  PMID: 33002671 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Transplant Vascular Dapartment

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 28, 2026
• Study Start: December 10, 2024
• Primary Completion: October 20, 2025
• Study Completion: December 9, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)