Integration of Donor-derived Cell-free DNA With HLA-DR+TNFR2+ Regulatory T Cell in the Prediction of Acute Rejection and Graft Function After Kidney Transplantation

What this Trial Is About

Researchers are investigating ways to improve the early diagnosis of acute rejection in kidney transplant recipients to enhance long-term graft survival. This study focuses on measuring donor-derived cell-free DNA (dd-cfDNA) and highly suppressive regulatory T cells (HLA-DR+TNFR2+ Tregs) to better predict acute rejection, especially lower severity T-cell mediated rejection, and future kidney graft function. The study aims to combine these two markers to improve prediction accuracy beyond current methods that rely on serum creatinine and invasive biopsies. The study will measure plasma dd-cfDNA and HLA-DR+TNFR2+ Tregs in 150 adult kidney transplant recipients at scheduled intervals during the first 6 months after transplantation. These measurements will help test a predictive model for acute rejection and graft function. The study uses advanced bioinformatics and molecular techniques to assess these biomarkers without needing donor or recipient genotyping. Participants are observed without specific treatment assignments as this is an observational trial. Participants will be monitored through blood tests measuring dd-cfDNA and Treg levels during the first 6 months post-transplant. Researchers will analyze how well these markers predict biopsy-proven acute rejection within one year and graft failure, defined as return to dialysis or death. The study will use statistical methods to evaluate predictive accuracy and assess the relationship between early biomarker levels and long-term kidney function. Participant involvement includes regular blood sampling and clinical follow-up for up to one year.

Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection