Bortezomib in combination with standard-of-care for late active antibody-mediated rejection with de novo donor-specific antibodies after kidney transplantation: a multicenter randomized trial.

Authors

Renaud Snanoudj, Fabienne Marquant, Karine Renaudin, Valérie Dubois, Alice Koenig, Nadia Arzouk, Sophie Caillard, Magali Giral, Arwa Jalal Eddine, Hakim Mazouz, Nassim Kamar, Vincent Pernin, Marie Matignon, Nacera Ouali, Dany Anglicheau, Caroline Elie

Published in

Transplant international : official journal of the European Society for Organ Transplantation. Volume 39. Pages 16702. Epub Sep 23, 2026.

Abstract

Bortezomib has been proposed as a treatment for antibody-mediated rejection (AMR) after kidney transplantation; however, its efficacy remains uncertain. We conducted a multicenter, randomized, open-label trial in France between February 2015 and July 2019 in adult kidney transplant recipients with late active AMR associated with de novo donor-specific antibodies (dnDSA). Sixty of the planned 100 patients were randomized 1:1 to receive standard-of-care consisting of corticosteroids, plasmapheresis, and intravenous immunoglobulin, either alone or with bortezomib administered as two cycles of four infusions. The primary endpoint was a composite of a >50% reduction in immunodominant DSA mean fluorescence intensity and stabilization or improvement of microvascular inflammation and transplant glomerulopathy on graft biopsy at 12 months. This endpoint was achieved in 40.0% of patients receiving bortezomib and 33.3% receiving standard-of-care alone in the intention-to-treat analysis (RR = 1.20, 95% CI 0.61-2.34; p = 0.59), and in 50.0% and 42.1%, respectively, in the per-protocol analysis (RR = 1.19, 95% CI 0.60-2.36; p = 0.62). Neither component differed between groups. Serious adverse events occurred in 23 patients (76.7%) receiving bortezomib and 14 patients (46.7%) receiving standard-of-care alone (p = 0.017). Adding bortezomib did not demonstrate a significant efficacy benefit and was associated with a higher incidence of serious adverse events (ClinicalTrials.gov number: NCT02201576).

PMID:
42846119
Bibliographic data and abstract were imported from PubMed on 08 Oct 2026.

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