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Biomarker-Guided Immunosuppression Withdrawal After Antithymocyte Globulin and Rituximab Induction in Low-Risk Living-Donor Kidney Transplant Recipients: A Prospective Mechanistic Pilot Trial

Abstract

Background: Durable operational tolerance after kidney transplantation remains uncommon. Most immunosuppression-withdrawal strategies have relied on calendar-based tapering rather than biologically informed decision-making. We tested whether biomarker-guided immunosuppression withdrawal could improve the safety and feasibility of minimization after living-donor kidney transplantation. Methods: This prospective, single-arm, open-label pilot study enrolled 22 adult, low-immunologic-risk recipients of primary living-donor kidney allografts between January 2021 and June 2022. All participants received induction with rabbit antithymocyte globulin and rituximab, followed by tacrolimus-, sirolimus-, and short-course mycophenolate-based maintenance without chronic corticosteroids. Withdrawal was initiated only after a predefined biomarker gate was satisfied, incorporating stable graft function, absence of donor-specific HLA antibodies, reassuring protocol histology, and a favorable composite immune-reconstitution profile. The primary endpoint was successful complete withdrawal of maintenance immunosuppression for 52 consecutive weeks without biopsy-proven acute rejection, donor-specific antibody development, recurrent disease, graft loss, death, or sustained graft dysfunction. Results: Fourteen of 22 recipients (63.6%) met biomarker eligibility for tacrolimus withdrawal at a median of 34 weeks (IQR 31–37) after transplantation, and 10 (45.5%) subsequently met eligibility for full withdrawal and discontinued all maintenance immunosuppression. Seven recipients (31.8%) met the primary endpoint. Overall biopsy-proven acute rejection occurred in 3 of 22 recipients (13.6%), all T cell-mediated; no antibody-mediated rejection occurred. De novo donor-specific HLA antibodies developed in 2 recipients (9.1%). There were no cases of patient death or graft loss. In exploratory analyses, recipients who met the primary endpoint showed higher transitional B-cell fractions (18.4% vs. 11.5%), higher naive-to-memory B-cell ratios (2.6 vs. 1.4), lower CD8+ TEMRA frequencies (21.7% vs. 31.9%), higher Treg/CD4 ratios (0.079 vs. 0.058), and lower serum BLyS concentrations (1.6 vs. 3.1 ng/mL) at the prewithdrawal biomarker assessment than recipients who failed to achieve durable withdrawal. Conclusions: In this pilot study, biomarker-guided immunosuppression withdrawal was associated with a subset of low-risk living-donor kidney transplant recipients in whom complete immunosuppression withdrawal appeared feasible with acceptable short-term safety. These hypothesis-generating findings support further prospective validation of immune-state-guided minimization strategies in larger cohorts.

Keywords: Immunosuppression withdrawal; Kidney transplantation; Biomarkers; Tolerance; Depletion induction
Copyright © 2025 Clyde F. Barker, Aneesha Agarwal and Patil Ashwin. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.